FDA is once again being criticized for its actions (or shall we say inactions) with the recent spate of recalls. The Washington Post reported that FDA was aware of contamination problems at a Georgia peanut butter plant years before a salmonella outbreak. An FDA report shows that FDA inspectors checked into complaints about contamination in [...]
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Last week FDA announced a voluntary nationwide recall of all lots of Listerine Agent Cool Blue Plaque-Detecting Rinse. The FDA said the manufacturer of the rinse, McNeil-PPC Inc., a Johnson & Johnson subsidiary, decided to recall approximately 4 million bottles after finding the rinse had been contaminated with microorganisms. Training TipIn your GMP training session, [...]
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On March 13, Abbott Laboratories, Inc. received another Warning Letter from FDA, this time for their Diagnostics Division operation in Dallas. This follows a Consent Decree that the Abbott Diagnostics Division received from FDA in 1999 for the Abbott Park operation in Illinois. Some of you may remember the 1960’s folk song, Where Have All [...]
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Last week, David Markovitz, President of GMP Training Systems, Inc. lectured on Implementing FDA’s Quality System Guidance at a conference on Quality Systems sponsored by Advanstar Communications and the Institute of Validation Technology. Last October David conducted this same program as an audio seminar. The audio recording of this seminar as well as the handout [...]
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