US FDA cites Apotex's Bangalore drug facility for fraudulent data
Jun 18 2014 , Bangalore
The letter, dated June 16, referenced an FDA inspection that took place in January at the company's facility in Bangalore, where inspectors found significant deviations from good manufacturing practices.
The inspection found that the company, which makes pharmaceutical ingredients, routinely completed sample analyses and recorded the data only if the results were acceptable.
"If the results obtained were atypical, a fresh sample was to be prepared and analyzed," the FDA said in its letter. "The original sample testing was not recorded."
In April, the FDA banned imports from the facility, saying it did not comply with quality standards. The move followed similar bans on certain products from Indian drugmakers Ranbaxy Laboratories Ltd, Wockhardt Ltd and Sun Pharmaceutical Industries Ltd.
The FDA said a response by privately held Apotex in February to the agency's inspection report "lacks sufficient corrective actions" and that the issues raised during the inspection "demonstrate a general lack of reliability and accuracy of data generated by your firm's laboratory."
The agency said the company's failure to create and maintain accurate documentation "is a repeat observation reported to your facility during the 2006 and 2010 inspections."
The FDA said that until the company corrects all the deviations, it may withhold approval of any new product applications.
Apotex officials were not immediately available.