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DRUG RECALL TOTALS FOR 2005

This article was originally published in The Gold Sheet

Executive Summary

...show the impact of FDA findings of serious GMP and data integrity problems at Able Labs from which the firm could not recover. The recall of all of Able’s marketed products accounted for more than one-sixth of the 254 products called back during the year. FDA cited inadequate oversight by the quality unit and senior management in its findings that Able was not following procedures for release and stability testing and was burying failing results. Contamination-related recalls were up in 2005 as were those given a Class I rating. CBER biological product deviation reports, which may presage recalls, also increased due to more allergenic filings. BPDRs involving product specification deviations continued to predominate while labeling problems doubled. [A nine-page tabulation of drug recalls listed in FDA "Enforcement Reports" during 2005 begins on p. 13.]

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