The FDA, which last month banned APIs coming from a Divi’s Laboratories plant in India, has followed that up with a warning letter that savages the facility for refusing to give inspectors records they needed to evaluate whether its drugs were adulterated.
The letter, posted Tuesday, savages the facility in Andhra Pradesh for extensive problems with the way Divi’s handled, and possibly manipulated and faked, data. It came after Divi’s last month reported that the agency had put its plant on its import alert list, while exempting 10 products manufactured there.
Among other problems, inspectors found that the plant had not been keeping audits of tests for some of its APIs, turning on the audit trail functionality only the day before the December 2016 inspection. Tests for out-of-specification investigations were conducted on equipment that was not protected from data deletions. Some equipment was purposely set to “mask identification and quantitation of impurities” in its APIs.
When inspectors asked for original records of some drug testing, employees repeatedly denied them access or gave them only copies that appeared to have had data changes, insisting they couldn’t provide originals without explaining why. Some of the records inspectors wanted were later found shredded in the trash.
The agency has ordered the company to do a top to bottom investigation into the extent of data integrity failings at the plant, suggesting that it be handled by an independent third party.