Rockville, MD (Feb. 1)—The US Food and Drug Administration (www.fda.gov) issued a revised warning letter to Actavis Totowa, LLC (Little Falls, NJ, www.actavis.us), citing “significant deviations from the current Good Manufacturing Practice regulations.”
FDA cites that during an inspection conducted Jul. 10–Aug. 10, 2006, several deviations from CGMP were observed, resulting in the adulteration of drug products manufactured in the facility. The deviations were presented on a FDA-483 (List of Inspections) at the close of the inspection on Aug. 10.
FDA cited deficiencies in the operations of the firm’s quality control unit, which included instances where the unit failed to adequately investigate and resolve laboratory deviations and out-of-specification test results for drug products.
In addition, laboratory notebooks were found to be incomplete, as they did not include all raw test data generated during testing. In addition, analysts did not always document the preparation and testing of samples at the time they were done.
FDA also cited a failure to check for accuracy the input and outputs from a system used to run the firm’s high-performance liquid chromatography during analysis of drug products.
Among other deficiencies cited: failure of the quality control unit to recognize that some tablets did not meet in-process specifications; a lack of adequate procedures for conducting bulk product holding time studies; failure to identify and control rejected in-process materials; inadequate cleaning validation studies; not adequately qualifying select equipment; and failure to establish and follow written procedures for maintaining manufacturing equipment.
Actavis has been given 15 working days to provide a written listing of all released lots of finished drug products that remain within specification that are associated with any out-of specification test results during manufacture and to provide description of the actions taken to ensure that lots were suitable for release.
The full letter from FDA may be viewed at http://www.fda.gov/foi/warning_letters/g6235d.pdf