FDA Cites Able For Failing To Reject Out-Of-Specification Drugs, Altering Data
Executive Summary
Able Labs routinely failed to reject drugs that did not meet established standards, specifications and quality control criteria, according to FDA inspectional observations included in a "Form 483" report
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Able continues to plead guilty in criminal proceedings
A sixth Able Laboratories manager has pleaded guilty to conspiracy in connection with the defunct firm's fraudulent testing and manufacturing practices, and he has indicated the direct involvement of at least one top executive. The six employees are all from Able's quality control department. In their plea agreements, the former employees describe a "secret project, directed by the highest levels of the company, which included forging data in chemist and laboratory notebooks and binders to obtain [FDA approval]," U.S. attorney Christopher Christie announces in an Aug. 7 press statement. All of Able's products were recalled from the market following multiple violations cited by FDA during good manufacturing practices inspections (1"The Pink Sheet" July 18, 2005, p. 31)...
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