GMP, cGMP, QSR and FDA Resource Library
Articles by David Markovitz
Personal Productivity
FDA Resources
Timely Resource Articles
cGMP for Dietary Supplements
We are Proud to Announce
Congratulations to one of our clients - VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center - for receiving the 2009 Malcolm Baldrige National Quality Award. We are privileged to share in your success!
The Malcolm Baldrige National Quality Award is the most prestigious Quality Award in the USA. Read a Press Release with details of their accomplishment. VA Cooperative Studies Program Clinical Research
Articles authored by David Markovitz
NEW!
Audit Preparation: A Key Element of an Effective GMP Training Process - This article describes an interactive exercise where groups prepare an audit checklist
NEW!
Taking Preventive Action: How Asking Good Questions Leads to the Root Cause of Problems - This article describes a method for getting to the root cause(s) of problems when conducting a Corrective and Preventive Action analysis
GMP Compliance: Start with the Basics This article outlines twelve fundamentals of GMP upon which to build an effective GMP Training Program
Turning Problems into GMP Learning Points This article discusses timely GMP training sessions focused on recent problems and issues
Have a Safe Flight This article discusses parallels between the FDA regulated industries and the airline industry. All our customers expect a "Safe Flight" when they buy and use our products
Think Before You Act This article provides strategies for improving your GMP training by incorporating the concept of Thinking before taking Action.
GMP and Quality, Responsibility, Integrity, and Accountability This article describes how to instill these important character traits into your people to assure commitment to GMP
Using Stories, Anecdotes, and Metaphors to Makes Your GMP Training Come Alive This article describes techniques for making your training become memorable experiences
Creating a Culture of Quality and GMP Compliance - This article describes characteristics of companies where Quality and GMP Compliance have become a Lifestyle
GMP Training in a Down Economy: Why It's More Critical Now Than Ever - This article will help you make the case for NOT cutting back on training in tough financial times
GMP Training: Keep it Fresh by Making it Real - This article contains tips on keeping your GMP fresh
GMP and Safety: Employee Safety and Customer Safety - This article discusses how to integate GMP training into your safety training sessions
Practical Preparation for Effective GMP Training Six Steps to Success! - First published in the Journal of GXP Compliance, this article is the first of three parts aimed at developing an effective GMP training process.
Conducting Effective GMP Training: Do’s and Don’ts for Success! - First published in the Journal of GXP Compliance, this is the second of three parts.
Effective Follow-up Strategies to GMP Training - First published in the Journal of GXP Compliance, this is the final of three parts.
A Risk-based Approach to GXP Training: One Size Does Not Fit All - First published in the Journal of GXP Compliance, this article explores developing an effective GMP training process in sync with FDA's new risk-based approach.
A System of Leadership for the 21st Century Lessons from Theodore Roosevelt - An unique perspective building on David's innovative approach of bringing Teddy Roosevelt Back to Life.
Problem Solving is Not Good Enough! Problem Prevention is the Key to Success - Effective use of After Action Reviews.
Personal Productivity
The Shallows - news item about Nicholas Carr's book, The Shallows, about what the Internet may be doing to our brains
Is Google Making Us Stupid? - article by Nicholas Carr
Wooden's Pyramid of Success - John Wooden's Pyramid of Success
The Wisdom of Wooden - Selected quotes from John Wooden
Change is the New Constant: Leading Organizations That (Can) Thrive in Crises - This short ebook describes seven steps for thriving in an unpredictable environment
100 Ways to Kill a Concept: Why Most Ideas Get Shot Down - This short e-book will help you become better at "selling" your ideas and creating a culture of innovation in your workgroup.
Innovation: More Than a New Year's Resolution - This short e-book will help you defy complacency in your work and career.
The Six Core Values of Innovation - This short e-book describes the six core values, or contexts, of innovation.
A Major Mistake That Managers Make - Article by Russ Ackoff, Ph.D.
A Little Book off-Laws: 13 common sins of management - Article by Russ Ackoff, Ph.D.
Transforming the Systems Movement - Article by Russ Ackoff, Ph.D.
From Mechanistic to Social Systems Thinking - Article by Russ Ackoff, Ph.D.
Questionating - This short e-book will help you develop your skill in asking questions. It was W. Edwards Deming who said, "The questions are more important than the answers."
Nelson Mandela's Lessons of Leadership - Excellent article from Time
FDA Resources
Most recent are at the top
FDA and EMA Joint Initiative for Inspections Jan 2012 - Read how this new cooperative arrangement will affect you
Janet Woodcock's view for the next 25 years of medicine Oct 2011 - Read this article outlining FDA's Janet Woodcock's views for the next 25 years of drug development
FDA's Investigations Operations Manual - Read Chapter 5 - Establishment inspections - from FDA's Investigations Operatsion Manual
Consent Decree announcement Sept 2011 - Read FDA's Press Release announcing a Consent Decree of Permanent Injunction against West Duluth Distribution Co., a manufacturer of Dietary Supplements
FDA Strategic Plan - Advancing Regulatory Science at FDA Aug 2011 - Read this new report from FDA
Speech by FDA's Senior Regulatory Counsel Aug 2011 - Read the speech by Carolyn Becker, FDA's Senior Regulatory Counsel, given at the GMP by the Sea Conference
FDA Guidance on Mobile Medical Applications July 2011 - Read FDA's proposed Guidance on Mobile Medical Applications
FDA on Internal Audits - What They Expect - Read this explanantion by FDA
General Navigation Guide for Manufacturers of FDA-Regulated Products and Start-ups - FDA's guide to determining whether your product is FDA regulated and in which category
FDA CDRH Innovation Initiative Feb 2011 - Center for Devices and Radiological Health proposed actions
FDA New Guidance on Process Validation Jan 2011 - Process Validation: General Principles and Practices
FDA Press Release on Improved 510k Process Jan 2011 - Read FDA's description of their improved 510k process
FDA 510k Report Jan 2011 - Read FDA's comprehensive report detailing the improved 510k process
FDA New Guidance Document for Dietary Supplements Dec 2010 - cGMP for Dietary Supplement Small Entity Compliance Guide
FDA Commissioner Warns Dietary Supplement Industry Dec 2010 - Read Commissioner Hamburg's letter to the Dietary Supplement industry
Tainted Products Marketed as Dietary Supplements Dec 2010 - Read FDA Consumer article regarding problems in the Dietary Supplement industry
FDA's Agenda for Guidance Documents in 2011 - Read this document outlining FDA's 2011 plan for adding new guidance documents and updating existing ones
FDA's Regulatory Science White Paper October 2010 - Read this twenty page landmark document from FDA
FDA Commissioner Hamburg's speech June 2010 - Read Dr. Hamburg's views on strengthening regulatory science
Public comments accepted by FDA on recordkeeping issues with Dietary Supplement GMP - Read this public notice published in the Federal Register on July 8, 2010
FDA Commissioner Hamburg's speech May 2010 - Innovation and the FDA: Past, Present, and Future delivered on May 15, 2010 at the Massachusetts Medical Society
FDA to Step up Criminal Prosecutions March 2010 - Read this news account
NovalisIntegra Close out Letter - Read this Close out letter issued by FDA after Warning Letter
Food Safety Tips for Healthy Holidays - FDA's guide published November 2009
ICH Q10 Pharmaceutical Quality System - Issued as a Guidance for Industry by FDA in April 2009
What FDA Does and Doesn't Regulate - This document clarifies what the FDA does and doesn't regulate
Sharfstein speaks on Supply Chain Safety Oct 2009 - Read a speech delivered by FDA Principal Deputy Commissioner Joshua Sharfstein, M.D. on Oct 22, 2009
Proposed GMP for Combination Products Sept 2009 - Read FDA's proposed new cGMP requirements for Combination Products
Sharfstein's comments Sept 2009 - Read comments from a speech delivered by FDA Principal Deputy Commissioner Joshua Sharfstein, M.D. “When public health is at stake, FDA is going to take this basic position: You can explain this problem to the public or we will.”
New England Journal of Medicine article June 2009 - Read this article by new FDA Commission Margaret Hamburg, M.D. and new FDA Principal Deputy Commissioner Joshua Sharfstein, M.D.outlining their vision for FDA
FDA's answer to Validation question Three Successful Batches? - Read this Q&A from FDA regarding the question of three successful batches to validate a process
FDA announces new policy for issuance of Warning Letters August 2009 - Read this Press Release with details of FDA's new policy on the issuance of Warning Letters
FDA Commissioner's Vision for Enforcement August 2009 - Read this speech delivered by FDA Commissioner Margaret Hamburg about her vision for enforcement
FDA Enforcement Statistics FY2008 - Chapter Ten from FDA booklet The Enforcement Story March 2009
FDA Glossary of Acronyms - Download your copy of FDA's acronyms
FDA Budget 2010 May 7, 2009 - Read FDA's Press Release describing their 19% budget increase request
FDA's Office of Criminal Investigations - Description of this office from FDA Consumer magazine
President Obama's Remarks about Food and Drug Safety and Nomination of New Commissioner - Read President Obama's speech of March 14, 2009 announcing the nomination of Dr. Hamburg for FDA Commissioner
Hamburg to Head FDA March 12, 2009 - News account indicating that Dr. Margaret A. Hamburg will be nominated to become FDA Commissioner
Cardinal Health 303 Inc. Amended Consent Decree February 2009 - Read this news account of why Cardinal Health 303 Inc. signed an amended Consent Decree with FDA over systemic issues in their operation
Cardinal Health Consent Decree February 2007 - Read this 27-page Consent Decree issued in 2007 for condemnation and permanent injunction
FDA's website on the peanut butter salmonella contamination issue - Visit FDA's website for up to date details
PCA's impact on small businesses February 28, 2009 - Read this news account of how the tainted peanut butter has caused small businesses (PCA's customers) to suffer
PCA's Texas plant FDA-483 report February 26, 2009 - Read this FDA-483 outlining deficiencies at PCA's Texas plant
PCA files for bankruptcy February 13, 2009 - Read this news report about PCA and their filing for bankruptcy
PCA owner appears before Congress and refuses to testify February 11, 2009 - Read this news report about PCA's owner and the Georgia plant manager, who both refused to answer questions at a Congressional hearing
PCA owner orders shipment of tainted products February 11, 2009 - Read this news account revealing internal e-mails where the company owner ordered shipments of salmonella contaminated products
Salmonella detected in Texas plan February 10, 2009 - Read this news account of the possible presence of salmonella at PCA's Texas plant
PCA shuts down plant in Texas February 10, 2009 - Read this news account on the Texas plant, which operated for four years unlicensed and uninspected by FDA and Texas health authorities
FBI raids PCA plant in Georgia February 9, 2009 - Read this news account of the FBI's raid on the plant at the core of the salmonella contamination
News report on the history of Peanut Corporation of America February 7, 2009 - Read this story on the history of problems this company has had with sanitation issues
Peanut Corporation of America Amended FDA 483 Report February 5, 2009 - Read this eight-page FDA 483 report, amended after FDA uncovered PCA knowingly shipped products contaminated with salmonella
Inspection Reports of PCA Plant February 1, 2009 - Read this news account of various inspections of Peanut Corporation of America's processing plant
FDA Opens Criminal Probe into Contaminated Peanut Products January 30, 2009 - Read this news account about the FDA and Dept. of Justice actions
Peanut Corporation of America FDA 483 Report January 27, 2009 - Read this six-page FDA 483 report issued regarding the peanut products contaminated with salmonella
FDA's new Commissioner's message January 21, 2009 - Frank Torti, M.D., MPH introductory message as FDA's Acting Commissioner
Good Importer Practices Guidance Document - Draft of new guidance for Good Importer Practices January 2009
FDA Acronyms - Glossary of FDA acronyms
Process Validation Guidance Document - Draft of FDA guidance on Process Validation: General Prinicples and Practices December 2008
Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals - Published in the Federal Register September 8, 2008, to go into effect December 8, 2008
FDA Presentation on Quality Program, CAPA and Audits - FDA's position on Quality Program, CAPA, and Audits
Laws Enforced by the FDA and Related Statutes - A listing of all the laws and statutes that the FDA enforces
Speech by FDA Commissioner Feb 29, 2008 - Read this speech entitled "FDA at a Turning Point: Meeting the Challenge of a Rapidly Changing World" byAndrew C. von Eschenbach, M.D.
Food Safety Tips for Healthy Holidays - FDA's Tips for Healthy Holidays
FDA Report - FDA Science and Mission at Risk November 2007 - Read this disturbing report commissioned by the FDA.
A Parent's Guide to Kids' Vaccines July 31, 2007 - FDA Consumer Health Information article
ICH Q10 Pharmaceutical Quality System guidance document, July 13, 2007 - Read this new guidance document available for public comment.
FDA Consumer Safety Office job description - Read the job description for an FDA Investigator (Consumer Safety Officer).
FDA presentation on ICH Q10- Presentation by FDA on ICH Q10 - Quality Systems
OOS Guidance Document - FDAGuidance for Industry issued October 12, 2006.
Quality Systems Approach to Pharmaceutical cGMP Regulations - Guidance document issued September29, 2006.
Implementing Quality Systems - PowerPoint presentation by Chris Joneckis, PhD FDACBER August 2006
Current Good Tissue Practice Regulation - FDA's regulation implemented in 2005.
FDA Manuals, Regulatory Publications, and Reports - A listing of all the FDA Manuals, Regulatory Publications, and Reports
Current Good Tissues Practice Guidance Document - FDA Guidance for Industry issued September 2006.
FDA Enforcement Report Aug 9,2006 - Selected excerpts from FDA's Enforcement Report highlighting GMP issues.
Small Business Guide to FDA - FDA's handbook for small business. Contains information about FDA's organization, procedures, policies, and regulations.
Human Drug CGMP Notes March 1999 - FDA's reference to Process Validation and "three consecutive batches"
FDA's Deputy Commissioner Speech, March 14, 2006 - Scott Gottlieb, MD, FDA's Deputy Commissioner for Medical and Scientific Affairs address at the 30th International Good Manufacturing Practices Conference at the University of Georgia College of Pharmacy
The Regulation of Dietary Supplements - Congressional testimony by the FDA Director of the Center for Food Safety and Applied Nutrition on March 9, 2006
FDA Enforcement Report February 1, 2006 - A sample of FDA's weekly Enforcement Report
Dispute Resolution Guidance - Formal Dispute Resolution: Scientificand Technical Issues Related to Pharmaceutical cGMP Guidance Document issued January 11, 2006
Centennial of the1906 Pure Food and Drugs Act - First in a series of articles in 2006 that will highlight some of the popular perceptions of the 1906 Pure Food and Drugs Act
FDA Recall Data for FY 2005 - CDER recalls in FY 2005, Top Ten reasons
Innovation or Stagnation - Important report issued by FDA in March 2004, and revised and updated in 2005.
Timely Resource Articles
Most recent are at top
Pfizer recalls Birth Control Pills after Mix-up in Packaging Feb 2012 - This this news account of the inspection failures in packaging operations
Ranbaxy Consent Decree Jan 2012 - Read this 60-page Consent Decree of Permanent Injunction
FDA Press Release regarding Ranbaxy Consent Decree Jan 2012 - Read this Press Release from FDA
Ranbaxy Consent Decree news account Jan 2012 - Read this account with more details of Ranbaxy's troubles with U.S. FDA
Novartis recall information Jan 2012 - Read the news account of recall of Novartis products
Novartis Consumer Health FDA-483 Observation Report - Read this FDA-483 issued to Novartis Consumer Health in 2011
Ranbaxy Consent Decree Announcement Dec 2011 - Read Ranbaxy Laboratories, Ltd announcement
Ranbaxy news regarding Consent Decree Dec 2011 - Read this news account
Ranbaxy article regarding Consent Decree impact Dec 2011 - Read this article
Ben Venue Laboratories, Inc. FDA-483 Dec 2011 - Read this 11-page Observation Report
KV Pharmaceutical Co. doubtful about future as a viable concern Dec 2011 - Read this news report
KV Pharmaceutical Co. Shuts Down its Ethex unit and Pleads Guily to Criminal Charges March 2010 - Read two news accounts of fallout from KV's compliance troubles
KV Pharmaceutical Co. Consent Decree March 2009 - Read FDA's Press Release about KV Pharmaceutical Co. Consent Decree
KV Pharmaceutical Co. FDA 483 Observation Report February 2009 - Read this 37 page FDA-483 Observation Report
FDA Shuts Down Dietary Supplement Manufacturer Nov 2011 - Read FDA's Press Release with details
Merck Pleads Guilty and Pays $950M Settlement Nov 2011 - Read this article with details
FDA on Recalls and Quality Defect Reporting Nov 2011 - Read this Q&A report from FDA
Insights into Tylenol Recall Oct 2011 - Read this article with insights into the problems facing McNeil Consumer Healthcare
FDA needs to create Chief Innovation Officer Oct 2011 - Read this article encouraging FDA to create a position of Cheif Innovation Officer
Hill Dermaceuticals, Inc., and Hill Labs, Inc. Consent Decree Sept 2011 - Read FDA's Press Release announcing this Consent Decree
Lonza Biologics, Inc. Warning Letter September 2011 - Read this Warning Letter citing inadequate failure investigations
Deibel Laboratories of Illinois, Inc. Warning Letter September 2011 - Read this Warning Letter citing inadequate failure investigations
Luitpold Pharmaceuticals, Inc. Warning Letter August 2011 - Read this Warning Letter citing inadequate failure investigations
Beckman Coulter Inc. Warning Letter August 2011 - Read this warning letter with citations in Design Control and CAPA
Top 3 GMP Violations in Dietary Supplement Companies August 2011 - Read this article outlining what FDA is finding in the Dietary Supplement industry
H&P Industries article - Read this article outlining issues at H&P and patient problems
H&P Industries, Inc. enters Consent Decree June 2011 - Read this news account following a FDA-483 and product seizures in April 2011
H&P Industries, Inc. FDA-483 Observation Report Jan 2011 - Read this thirty page, 46 count Observation report
H&P Industries plant shut down by FDA April 2011 - Read this news account of a Wisconsin manufacturer of OTC products being shut down by FDA as well as comments from ex-employees
Layoffs at Anulex after FDA Warning Letter April 2011 - Read this news account quoting the President of Anulex that the warning letter was "extremely disruptive to business"
Anulex Warning Letter Feb 2011 - Read the Warning Letter issued to Anulex Technologies Inc.
Ortho McNeil Nuerologics recall Apr 2011 - Another recall from a Johnson & Johnson company - now over 300 million bottles and packages in the last 15 months
Vital Nutrients Warning Letter Feb 2011 - Read this Warning Letter issued to a manufacturer of dietary supplements
Vital Nutrients Quality Statements - Read these statements from Vital Nutrient's web site
NBTY, Inc. EIR Report - Read this Establishment Inspection Report
NBTY, Inc. FDA-483 Observation Report - Read this FDA-483 issued to a manufacturer of dietary supplements
Terumo Cardiovascular Systems Corp. Consent Decree Mar 2011 - Read FDA's announcement of this Consent Decree and $35M fine
FDA Press Release Mar 2011 - Read FDA's Press Release announcing the Consent Decree of Permanent Injunction with McNeil-PPC, Inc.
McNeil-PPC, Inc Press Release Mar 2011 - Read McNeil's Press Release announcing the Consent Decree
Johnson and Johnson List of Recalls Mar 2011 - Read this comprehensive listing of product recalls by Johnson and Johnson companies in 2010 and 2011.
Cordis Warning Letter Feb 2011 - Read this Warning Letter issued to a Johnson and Johnson company for shipping defective heart stents
Deston Therapeutics LLC Warning Letter - This letter was issued in February 2010, and this company has now had products seized by federal marshals (Feb 2011) because products were not approved by FDA
All American Pharmaceutical & Natural Foods, Corp. Warning Letter Jan 2011 - Read this Warning Letter issued for violations of the new Dietary Supplement GMP21 CFR Part 111
Scientific Protein Laboratories LLC Warning Letter Jan 2011 - Read this Warning Letter outlining various violations of Drug GMP 21 CFR Part 210 and 211
Deltex Pharmaceuticals, Inc. Consent Decree Jan 2011 - Read FDA's Press Release announcing this Consent Decree requiring a recall of all products manufactured since Oct 2008
Deltex Pharmaceuticals, Inc. Warning Letter from Oct 2008 - Here is the Warning Letter cited in FDA's Press Release regarding Deltex Pharmacuticals
McNeil Healthcare recalls more Tylenol Jan 2011 - Read this news account where FDA slams McNeil for their slow response to system issues
McNeil Healthcare FDA-483 Jan 2011 - Read this eight page FDA-483 observation report
Genzyme moves jobs overseas Nov 2010 - Read this news account about Genzyme moving jobs from the US to Ireland after a Consent Decree and $175M fine
McNeil Healthcare FDA-483 Nov 2010 - Read this ten page FDA-483 observation report
Gilead Sciences, Inc. Warning Letter Sept 2010 - Read this Warning Letter with citations regarding Environmental Monitoring and Cleaning Validation
Glaxo SmithKline pleads guilty and pays $750M fine for adulterated drugs Oct 2010 - Read this article about GSK's Puerto Rico facility and the fine of $750M for not following GMP
FDA initiates Kelsey Award - Read this article about Dr. Frances Kelsey and how her work in 1961 led to the development of GMP
Taste of Raspberries, Taste of Death - Read this chilling account of the 1937 Elixir of Sulfanilamide tragedy
The Birth of CGMPs - Read this article by FDA Historian Dr. Suzanne White Junod about the beginnings of the CGMP regulation.
How Theodore Roosevelt Made Your Dinner Safe to Eat - Read this fascinating article published in American Heritage Magazine on June 29,2006
Protecting America's Health - Read this review of Philip J. Hilts' book, Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation.
Centennial of The Jungle - Read this fascinating story published on May 31, 2006 about the intricacies of how the landmark book, The Jungle by Upton Sinclair, led to the Pure Food and Drugs Act of 1906.
J&J and FDA leaders take heat from Congress Oct 2010 - Read this news account of a Congressional hearing on J&J's "phantom recall" of Motrin
Abbott recalls baby formula Sept 2010 - Read FDA's announcement of Abbott's recall of certain lots of baby formula becuase of possible contanimation with insect parts
Sun Pharmaceutical Industries, Inc.Warning Letter August 2010 - Read this Warning Letter, scroll down to July 2009 to see Warning Letter and product seizure at Sun division, Caraco Laboratories
Johnson and Johnson's 11th recall this year August 2010 - Read a news account of J & J and the 11 recalls this year - so far
Nitrox, Inc. Warning Letter July 2010 - Read this Warning Letter where FDA says to use "Good Science"
Johnson & Johnson Merck Consumer facility FDA-483 Observation Report July 2010 - Read this FDA-483 citing documents not being readily available for review by FDA inspectors
Abbott Laboratories Warning Letter July 2010 - Read this warning letter issued to a division of Abbott Labs. This is Abbott's 18th warning letter since 1997.
Piezosurgery Inc. Warning Letter June 2010 - Read this warning letter citing ineffective customer complaint handling and failure to document employee training
American Red Cross Fined Again $16M June 2010 - Read this news article where the American Red Cross was fined once again for GMP violations
Congressman Edolphus Towns Closing Statement May 2010 - Read this closing statement from the Congressional Hearing on Johnson and Johnson's recall of children's Tylenol and other children's medicines
FDA Deputy Commissioner Sharfstein's Testimony before Congress on Tylenol recall May 2010 - Read Sharfstein's testimony on Johnson and Johnson's recall of children's Tylenol and other children's medicines
Johnson and Johnson's testimony before Congress on Tylenol recall May 2010 - Read Colleen Goggins, Worldwide Chairman, Consumer Group, Johnson and Johnson, testimony on Johnson and Johnson's recall of children's Tylenol and other children's medicines
Advanced Sterilization Products Warning Letter Mar 2010 - Read this Warning Letter issued to a division of Johnson and Johnson
Perrigo Warning Letter Apr 2010 - Read this Warning Letter issued for shipping Ibuprofen tablets contaminated with metal shavings
Coats International Holdings Warning Letter March 2010 - Read the first Warning Letter issued for compliance issues with 21CFR Part 111 - Dietary Supplements GMP
Genzyme's Consent Decree May 2010 - Read this 44-page court injunction
Genzyme signs Consent Decree; Pays $175M fine May 2010 - Read FDA's Press Release with details. Scroll down for more on Genzyme
Genzyme's Press Release regarding Consent Decree May 2010 - Read Genzyme's Press Release
FDA Surprised by GMP Violations in Dietary Supplement companies May 2010 - Read this article where a senior FDA adviser lists several GMP violations found in dietary supplement companies
FDA to expand investigation into McNeil Consumer Healthcare's operations May 2010 - Read this news account about FDA looking for similar problems throughout the company
J&J CEO status May 2010 - Read these two articles about J&J's CEO and his comments regarding the Tylenol recalls
McNeil Consumer Healthcare Suspends Production May 2010 - Read McNeil's statement where they announce a temporary suspension of production
McNeil Consumer Healthcare in the news May 2010 - Read two news articles regarding the troubles at McNeil Consumer Healthcare
McNeil Consumer Healthcare Product Recall website - McNeil has established a website for consumers to learn about the recalled products and apply for refunds
FDA-483 issued to McNeil Consumer Healthcare on April 30, 2010 - Read this seventeen page FDA-483 report. One could design an entire GMP training course around these observations
McNeil Consumer Healthcare recalls Children's Tylenol May 2010 - Read two news accounts of McNeil Consumer Healthcare's continuing GMP issues
McNeil Consumer Healthcare Warning Letter January 2010 - Read this Warning Letter
Tylenol recall due to wooden pallets January 2010 - Read this news account of over 500 lots of product being recalled
McNeil Consumer Healthcare FDA-483 January 2010 - Read this FDA-483 Observation Report issued to McNeil Consumer Healthcare, makers of Tylenol
Apotex Inc. Warning Letter March 2010 - Read this Warning Letter where FDA says their response to previous warnings "is inadequate and lacks sufficient corrective actions."
Genzyme to Pay $175M Fine - Read this article about Genzyme's first quarter performance and the fine they expect to pay
More on Genzyme's troubles with FDA - Read this article with a chronicle of fourteen years of trouble with FDA
Genzyme announces pending Consent Decree from FDA - Read Genzyme's announcment from March 24, 2010
Genzyme's troubles with FDA - Read three news accounts detailing Genzyme's troubles with FDA
Genzyme contamination - Read this article about how FDA inspectors found bits of steel and rubber in injectable drugs November 2009
Genzyme Warning Letter - Read this Warning Letter issed to Genzyme Corp. in February 2009
Jail Time for Executives Might Stop Drug Crimes - Read this interesting article about FDA's more rigorous pursuit of criminal prosecutions
HMI Industries, Inc. Warning Letter February 2010 - Read this Warning Letter citing CAPA and Customer Complaint handling deficiencies among other problems.
Kellogg's news account February 2010 - Read this news account regarding contaminated Eggo Buttermilk waffles
Kellogg's receives Warning Letter January 2010 - Read this Warning Letter outlining cleaning issues
FDA Enforcement Letters are UP! February 2010 - Read this news account about the steep increase in FDA Enforcement Letters.
U.S. Marshals Seize Unapproved Medical Devices January 2010 - Read this news account where the owner of a company denied FDA entry for an inspection
Won Feng Trading, Inc. Warning Letter issued May 2009
- Read this Warning Letter describing horrific conditions. FDA seized a $1 million of products on Jan 6, 2010
Pan American Labs Warning Letter November 2009 - Read this Warning Letter with a good description of "medical foods."
FDA Tightens 510K Review Process Sept 2009
- Read this article outlining FDA's tighter approach to the 510K review process for medical devices
Washington Homeopathic Products, Inc. Warning Letter August 2009 - Read this Warning Letter issued after inadequate and/or no action taken after receiving an FDA-483 Observation Report
FDA Gets Tough August 2009 - Read this article from Newsweek
US Marshals Seize Contaminated Hand Sanitizer August 2009 - Read this article with details on the kind of trouble your company can face by not following cGMP
Advanced Neuromodulation Systems, Inc. Warning Letter June 2009 - Read this eight page Warning Letter. A good example of the lack of a systems approach to quality.
FDA files for Consent Decree against Quality Formulation Laboratories, Inc. (Dietary Supplement company) July 2009 - Read FDA's Press Release citing cGMP violations (including live and dead rodents) that led to a permanent injunction Consent Decree filing
Quality Formulation Laboratories FDA 483 Observations January 2009 - Read this eight-page FDA 483 issued to Quality Formulation Laboratories
Caraco announces layoffs July 2009 - Caraco Pharmecetucial Laboratories, Inc. lays off over half its work force due to GMP issues
U.S. Marshals Seize Drug Products at Caraco Pharmaceutical Laboratories, Ltd. June 2009 - Read FDA's Press Release and a news account of this action
Caraco Pharmaceutical Laboratories, Ltd. Warning Letter - Read this Warning Letter issued in October 2008
Nestle USA Refuses Access to FDA - Read this news article about Nestle's refusal to allow FDA to take photos and denial of access to certain documents
Howard Instruments, Inc. Warning Letter May 2009 - Read this eight page Warning Letter with details on the lack of training and training documentation
CheeriosTM Warning Letter May 2009 - Read this Warning Letter issued to General Mills regarding medical claims for CheeriosTM cereal
San Francisco Chronicle news account of P&G Warning Letter May 2009 - Read this news account from the San Francisco Chronicle about P&G's Warning Letter issued in Puerto Rico
Proctor and Gamble Warning Letter April 2009 - Read this Warning Letter issued to P&G's Puerto Rico facility
Duct Tape and Vendor Audits April 2009 - Read this news article with more lessons from the peanut butter salmonella case. This will make your jaw drop.
FDA Gearing Up for a More Activist Role April 2009 - Read this news story regarding a shift in the FDA.
Consent Decree for Neilgen Pharmaceuticals, Inc. and Advent Pharmaceuticals, Inc. April 2009 - Read FDA's Press Release announcing another Consent Decree
Consent Decree and Plant Shutdown March 2009 - Read FDA's Press Release announcing the shutdown of a tortilla manufacturer for GMP violations
Is FDA Broken? March 2009 - Read this news story regarding FDA which includes speculation on who may be the new FDA Commissioner
- Feb 2009 - Read this story of how falsifying records gets two execs prison time
Canada quarantines Ranbaxy's products Feb 28, 2009 - Read this article about Health Canada placing a quarantine on Ranbaxy's products
Ranbaxy Labs falsifies data Feb 25, 2009 - Read FDA's Press Release where they found that Ranbaxy has falsified data and test results
FDA's letter to Ranbaxy Labs Feb 25, 2009 - Read FDA's letter to Ranbaxy Labs
India Business-Standard article about Ranbaxy Laboratories Sept 18, 2008 - Read this news account about Ranbaxy's financial performance and expected buy-out by a Japanese company
Forbes article about Ranbaxy Laboratories Sept 16, 2008 - Read this news account published in Forbes
Ranbaxy Laboratories Warning Letter #2 Sept 16, 2008 - Read this thirteen page Warning Letter issued to a second facility in India
Ranbaxy Laboratories Warning Letter Sept 16, 2008 - Read this seven page Warning Letter to a company based in India
Twelve arrested in Diethylene Gycol tainted medicine February 11, 2009 - Read this news account from Nigeria where 84 children died as a result of using this poisoned product
Brain Food, Wizard Oil, and other Nostrums Dec 16, 2008 - FREE graphics you can use in your GMP training
Obama to strengthen FDA Nov 6, 2008 - Read this news article about FDA in an Obama administration
Heparin seizure Nov 6, 2008 - Eleven lots of contaminated heparin seized by U.S. marshals from Celsus Laboratories, Inc. in Cincinnati
GAO Report issued Oct 22, 2008 - Read the Government Accountability Office's 53-page report, "Drug Safety: Better Data Management and More Inspections Are Needed to Strengthen FDA's Foreign Drug Inspection Program"
News articles about GAO Report Oct 22, 2008 - Read these news reports about the GAO report condemning FDA's ability to monitor foreign drug manufacturers
NeoChild LLC Warning Letter July 29, 2008
- Read this eight page Warning Letter detailing ineffective responses to a FDA 483 Notice of Observations
Volk Optical, Inc. Warning Letter July 7, 2008 - Read this five page Warning Letter
Carematix Inc. Warning Letter July 3, 2008 - Read this eight page Warning Letter
Anika Therapeutics, Inc Warning Letter July 2, 2008 - Read this nine page Warning Letter
Written Procedures and the Incoming Workforce - A list of interesting facts regarding those entering the workforce in 2008. An example: They grew up with digital clocks. Half past three or quarter to four may have no meaning to them.
Keep your GMP Training ALIVE! Table Topper example - June 15, 2008 - Here's an example of a Table Topper you can use in Keeping Your GMP Training Alive
FDA Staff in Crisis - June 8, 2008 - Read this news account of FDA staffers leaving the FDA, where the average age is 54
Warning Letters Drop in Number June 6, 2008 - Read this news report about the Enforcement Shift at FDA
Scientific Laboratories Inc. Consent Decree May 16, 2008- Read this Press Release from FDA announcing the Consent Decree signed by Scientific Laboratories Inc.
Merck Warning Letter April 28, 2008- Read this nine page Warning Letter issued to Merck and Company, Inc.
National Biological Corp. Warning Letter April 23, 2008 - Read this Warning Letter dealing with customer complaint handling and caPA (Corrective and Preventive Action)
Trying Times at the FDA: The Challenge of Ensuring Safety of Imported Pharmaceuticals April 24, 2008 - New England Journal of Medicine article
The Heparin Fiasco April 10, 2008 - Read this New York Times story with details
Philips Lifeline, Inc. Warning Letter February 29, 2008 - Read this Warning Letter issued to a Medical Device manufacturer
Testimony of Sidney Wolfe, M.D. before Congress February 27, 2008 - Read Dr. Wolfe's testimony citing a crisis in leadership in the FDA.
Baxter's explanation of the heparin incident Feb 19, 2008 - Read Baxter's explanation about the heparin incident.
FDA Mixed-up Drug Plant Names in China Feb 19, 2008 - Read this news article about FDA's mix-up and Baxter's troubles with heparin, a blood thinner.
Congressman Calls for FDA Commissioner to Resign Feb 15, 2008 - Read this news account about FDA getting blamed by a Congressman for recent problems.
Red Cross announcement of fine - February 7, 2008 - Read The Red Cross' announcement regarding the new fine.
FDA Fines Red Cross $4.6M February 7, 2008 - FDA assesses another fine on the American Red Cross for distribution of unsuitable blood products. Fines in recent years now total more than $19 million.
Vintage Pharmaceuticals, LLC Warning Letter February 1, 2008 - Read this Warning Letter issued because of an inadequate response to a Form FDA 483, List of Inspectional Observations.
Recall Notice of Contaminated Syringes January 18, 2008 - Heparin and Saline pre-filled flushes recalled due to bacterial contamination.
Noven Pharmaceuticals, Inc. Warning Letter January 4, 2008 -Read this Warning Letter issued because of an inadequate response to a Form FDA 483, List of Inspectional Observations.
G. Dundas and Company, Inc. Warning Letter December 13, 2007 - Read this Warning Letter issued because of an inadequate response to a Form FDA 483, List of Inspectional Observations.
Dirty Tank Leads to Contaminated Products - Read this news account of an API manufacturer who hadn't cleaned a holding tank with a key starting raw material in years, and how it led to several batches of product getting contaminated.
China Gets Serious on GMP - China's State FDA is ramping up its enforcement of GMP, working with US FDA on safety pact.
FDA Damned If It Does, Damned If It Doesn't - An interesting article published in Fortune about FDA's current strategies.
Med-South Pharmacy Inc. Warning Letter - An interesting look at drugs compounded by local pharmacies. Read FDA's comments on how these drugs are regulated.This is a good case study demonstrating the "c" in cGMP - keeping current with the ever evolving GMP regulation.
Tylenol is Different ad campaign - Look at Tylenol's new advertising campaign "Tylenol is different because of the people who make it."
Contaminated beef leads to company shutdown October 5, 2007 - Beef processor forced to recall one year's production and calls it quits
Proctor & Gamble Warning Letter September 14, 2007 - Read this Warning Letter detailing the difference between a sanitizer and a drug.
Swanson Health Products Inc.Warning Letter August 8, 2007 - Read this Warning Letter to a North Dakota company detailing the fine line between a Dietary Supplement and a Drug.
Sunburst Biorganics Warning Letter August 7, 2007 - Read this Warning Letterto a New York company detailing the fine line between a Dietary Supplement and a Drug.
AIDS drug recalled July 23, 2007 - Read this article from the New York Times detailing the impact on poor people in developing nations of this contaminated AIDS drug.
Chinese FDA Chief executed July 10, 2007 - Read this startling article on China's former head of their FDA executed for taking bribes.
Shelhigh Consent Decree June 22, 2007 - Read FDA's Press Release announcing this consent decree for a manufacturer of heart valves.
Imported Generic Drugs on the Rise June 17, 2007 - Read this Washington Post story about the increase in generic drugs from India and China and FDA's challenge in inspecting plants in these two countries.
Crystal Reflections International Warning Letter June 14, 2007
- Read thisWarning Letter issued to a manufacturer of contact lenses. The change control system consisted of "post-it" notes!
Chinese toothpaste advisory June1, 2007 - Read FDA's advisory to avoid toothpaste containing diethylene glycol made in China.
Advanced Medical Optics Recall of Contact Lens Solution May 25, 2007 - Read FDA's announcement of Advanced Medical Optics' recall of one of their contact lens solutions.
Advanced Medical Optics recall notice November 21, 2006 - Read this recall notice of a contact lens solution - contaminated batches
FDA Plans to Close Labs - Read this story from McClatchy Newspapers on this controversial plan by FDA to close and consolidate their laboratories May 2007
Senate debates bill to increase power and money for FDA - Read this story from The New York Times May 2007
FDA Comes Under Fire -AGAIN! - Read this story from the Washington Post April 2007
Abbott Laboratories, Inc. Warning Letter - Issued to Abbott Diagnostics Division in March 2007
Abbott Consent Decree -Read this landmark twenty-four page Consent Decree issued in 1999
Fisher and Paykel Healthcare Inc. Warning Letter - Issued February 2007
Medical Concepts Development Warning Letter - Issued February 2007
Niagara Pharmaceuticals Inc. Warning Letter - Issued February 2007
Rymed Technologies Inc. Warning Letter- Issued February 2007
First Check Diagnostics, LLC Warning Letter - Issued February 2007
GE Healthcare Technologies Warning Letter- Issued February 2007
Actavis Totowa, LLC Warning Letter -Issued February 2007
Edwards Life Sciences Warning Letter - Read this eight page Warning Letter issued inFebruary 2007
Cardinal Health Consent Decree - Read this 27-page Consent Decree for condemnationand permanent injunction.
FDA's announcement of Cardinal Health Consent Decree - Read FDA's reasons for obtaining this consent decree for condemnation and permanent injunction against Cardinal Health.
Whistleblowers Help Congress Strengthen FDA - Read this February 2007 article.
News account of GE OEC Medical Systems problems - Read this newspaper account about the problems facing this company.
GE OEC Medical Systems Warning Letter - Read this Warning Letter issued in March 2005.
GE OEC Medical Systems Consent Decree announcement - Read FDA's Press Release January 12, 2007 announcing this Consent Decree.
New Congress to Split FDA?- Published January 7, 2007. An article speculating that the new Democrat controlled Congress will split FDA into two agencies, one for the Foods industry, and one for the Medical industries.
Why Drug Prices are High - An informative article by syndicated columnist Jay Ambrose published December 11, 2006.
Boston Globe news article - Read this analysis of the impact of the November election and FDA as well as an analysis of FDA's action plan for Medical Device Post Market Monitoring
FDA Press Release - Medical Device Post Market Monitoring - Nov 9, 2006 - FDA's action plan for strengthening the way it monitors the safety of medical devices after they reach the marketplace.
Perrigo recalls acetominophen Nov 9,2006 - News story detailing recall of 11 million containers of acetominophen for metal fragments
Bausch and Lomb Warning Letter Oct 31, 2006 - Read this eleven page Warning Letter outlining systemic violations
Bausch and Lomb FDA 483 May 2006 - Read this eleven page FDA 483. Bausch and Lombissued a recall of one of their products the day after receiving this 483.
FDA Newsletter from November 1962 - Historic photos of President Kennedy upon the advent of GMP
GSK recalls Paxil - Missing Active Ingredient - October 5, 2006 news article
Graham's editorial published by JAMA - Dr. David J. Graham's editorial published by the Journal of the American Medical Association.
USA Today Sept 12, 2006 -Dr. Graham Speaks Out - Read this article where FDA official Dr .David J. Graham speaks out about new arthritis drugs.
American Red Cross fined by FDA September 8, 2006 - Read this Press Release from FDA explaining why the American Red Cross was fined $4.2 million for violating GMP regulations.
Command Medical Products Warning Letter August 17, 2006 - Read this short Warning Letter and gain insights into FDA's thinking.
FDA Commissioner Nomination Embroiled in Politics - Read this article published the day after the Senate held confirmation hearings on Andrew von Eschenbach's nomination as FDA's Commissioner.
FDA Q&A regarding Sanofi Pasteur Warning Letter - Gain valuable insights into FDA's thinking by reading this Question and Answer document released by FDA on July 3, 2006
Sanofi Pasteur Warning Letter June 30, 2006 - Read this seven page Warning Letter.
Sanofi Pasteur FDA 483 April 2006 - Read this eight page FDA 483.
Rep. Waxman's statement June 27, 2006 - Statement upon release of Prescription for Harm report
Prescription for Harm: The Decline in FDA's Enforcement Activity - Congressional report issued June 27, 2006 by Rep. Henry Waxman
Executives convicted May 3, 2006
- FDA's Press Release with details
FDA Cease Manufacturing Letter Jan 31, 2006 - FDA's letter to Biomedical Tissue Services Ltd
Schering-Plough's Consent Decree - Read this 46 page Consent Decree issued in May 2002 to Schering-Plough Corporation
Guidant Corp. Warning Letter Dec 2005 - Read FDA's Warning Letter as a follow-up to the Sept 2005 FDA 483
Guidant Corp. FDA 483 Sept 2005 - Read this seven page FDA 483 with fifteen major observations
Google's Ten Golden Rules Dec 2, 2005 - Newsweek article describing how Google manages "knowledge workers"
FDA Issues Consent Decree to MBI Nov 29, 2005 - Read FDA's Press Release
US Marshals seize infusion pumps, Oct 12, 2005 - FDA and US District Court work together to seize products manufactured by Baxter Healthcare Corp.
Jury Award in Vioxx Trial - August 18, 2005 - First jury award against Merck
Pharmakon Labs Shut Down July 27, 2005 - Read FDA's Press Release
Able Laboratories FDA 483 July 2005 -Read this fifteen page FDA 483 with twelve major observations.
Able Labs in USA Today July 12,2005 - Read this interesting story published in USA Today.
Continuous Improvement under Modern Quality Systems and cGMPs - FDA's Richard Friedman's presentation at the 2005 Drug Information Association meeting, June 26 -30 Washington DC
cGMP for Dietary Supplements
Reporting an Adverse Event for Dietary Supplements - August 2011 - Updated regulatory information from FDA
Draft Guidance: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues July 2011 - Read this proposed guidance
Warning Letter - Ethos Environmental, Inc. - May 2011
Warning Letter - Cerebral Health LLC - May 2011
Warning Letter - Hsu's Ginseng Enterprises, Inc. - May 2011
Warning Letter - God's Garden Pharmacy - May 2011
Warning Letter - Nuvonyx, Inc. - May 2011
Warning Letter - Reed's Inc. - May 2011
Warning Letter - Natural Path/Silver Wings LLC - April 2011
FDA New Guidance Document for Dietary Supplements Dec 2010 - cGMP for Dietary Supplement Small Entity Compliance Guide
Public comments accepted by FDA on recordkeeping issues with Dietary Supplement GMP - Read this public notice published in the Federal Register on July 8, 2010
FDA Guidance - Adverse Event Reporting and Recordkeeping June 2009 - FDA's new guidance
cGMP for Dietary Supplements Final Rule June 22, 2007 - FDA's Preamble and Final Rule to the Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
cGMP for Dietary Supplements 21CFR Part 111 - Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
FDA Press Release announcing cGMP for Dietary Supplements June 22, 2007 - FDA's Press Release
FDA's Background info on cGMP for Dietary Supplements June 22, 2007 - FDA's Backgrounder document
FDA Consumer article on new Safe Use of Dietary Supplements June 22, 2007 - FDA Consumer Health Information article
Definition of Adulteration- Section 402 of the Federal Food, Drug, and Cosmetics Act
