FDA discovered tablets left from previous runs in packaging and labeling equipment. This is among several violations listed in a Warning Letter issued to L. Perrigo Company by FDA. They also shipped tablets contaminated with metal shavings. GMP Tip Read Warning Letters like this one to see what FDA considers important and how FDA interprets [...]
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FDA has fined the American Red Cross $16M for GMP violations. FDA has already sent 12 letters and imposed over $21M in fines since 2003, not including this latest fine. GMP Tip The American Red Cross is caught up in a costly cycle of non-compliance. Preventing contamination, mix-ups, and errors is ALWAYS less expensive than [...]
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In what appears to be the first Warning Letter issued for violations of 21CFR Part 111, GMP for Dietary Supplements, FDA cited Coats International Holdings, Inc. for seven major violations. Observation Four says “Your Quality Control program is not adequate” and goes on to cite four specific examples. GMP Tip Learn how FDA is enforcing [...]
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Recently FDA Commissioner Margaret Hamburg spoke at the Massachusetts Medical Society on Innovation at the FDA: Past, Present, and Future. She does a nice job of describing the historical events leading to today’s FDA approach. GMP Tip Read Commissioner Hamburg’s speech and pick up some content you can incorporate into your GMP training sessions. To [...]
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On May 24, 2010, Genzyme Corporation signed a Consent Decree of Permanent Injunction in the United States District Court (Massachusetts) and agreed to pay a fine of $175M to the United States Treasury. GMP Tip Learn from other companies experiences and gain insights into FDA’s thinking. Read this 44-page Consent Decree. Go to: www.gmptrainingsystems.com/resources Click [...]
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FDA’s Principal Deputy Commissioner Joshua Sharfstein, M.D., testified at a Congressional Hearing on Johnson and Johnson’s recall of children’s Tylenol and other children’s medicines. In his testimony, Dr. Sharfstein does an excellent job of explaining the importance of GMP. At this same hearing, Congressman Edolphus Towns said he would be introducing legislation to give FDA [...]
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