Divi’s, Teva Draw Warnings Over GMP Problems
Divi’s Laboratories has been warned by the FDA for failing to meet current good manufacturing practice requirements, adding to the Indian drug manufacturer’s compliance woes.
The FDA also says Divi’s limited the agency’s inspection in November and December 2016, preventing access to audit trails from chromatographic drug-testing systems.
Other GMP deviations, according to the agency’s warning letter, included unsound product testing methods, lack of control over electronic GMP information and overall data integrity and access issues.
The warning letter comes on the heels of a FDA import alert that included Divi’s API manufacturing operation, though the agency exempted 10 products from the Visakhapatnam plant at the time.