FDA Issues Warning Letter to API Manufacturer Apotex Pharmachem India

FDA issued a warning letter to Apotex Pharmachem India on June 16, 2014 for cGMP violations for API manufacturing that FDA identified in an inspection of the Bangalore, India plant from Jan. 27 to Jan. 31, 2014. FDA cited failure to maintain complete data from laboratory tests, failure to investigate and document out-of-specification results, failure to include adequate documentation during complaint investigation, and failure to record activities at the time they are performed. In issuing the warning, FDA noted that the firm's response lacked sufficient corrective actions.

Regarding laboratory data problems, FDA noted a "general lack of reliability and accuracy of data generated by your firm's laboratory, which is a serious cGMP deficiency that raises concerns about the integrity of all data generated by your firm." FDA noted that the failure to create and maintain accurate documentation was a repeat observation reported to the facility during inspections in 2006 and 2010. The failure to perform adequate investigations of out-of-specification results had also been reported during these previous inspections.

FDA also noted that the company had been cited in 2010 inspections for failing to include adequate documentation during complaint investigations, and that the company did not implement the corrective actions it had committed to at that time. FDA called for the company to "explain the failure of your firm’s complaint system and how you will implement proper management oversight to ensure adequate corrections to this deficiency."

FDA found that "staff used 'finished product reports review data' worksheets to document critical laboratory information days after the actual testing was performed." FDA said that the examples found "raise serious concerns regarding the integrity, reliability, and accuracy of the data generated and available" at the facility.

Source: FDA