Indian API Manufacturer Cited for Quality Issues
Therapiva Private, an active pharmaceutical ingredient manufacturer in India, was hit with a Form 483 by the FDA for quality control unit and cleaning lapses.
An agency inspection of the facility in Telangana revealed that the firm was not conducting thorough out-of-specification investigations.
Therapiva was also cited for not training all of its employees in standard operating procedures. The agency investigators noted that some employees could not explain their assigned functions for testing U.S. marketed products.
The API manufacturer was also flagged for not qualifying suppliers of critical raw materials or contracted laboratories used to manufacture and test several finished APIs marketed in the U.S.