The U.S. FDA has issued a warning letter to Jubilant Generics for its Roorkee, North India facility.
The letter red flagged significant repeat violations of good manufacturing practices, stating that the drugmaker "did not adequately justify root causes, expand investigations to all potentially affected batches, implement corrective action and preventive actions in a timely manner, or evaluate CAPA effectiveness."
Additionally, said the warning, the quality control unit failed to test and reject out-of-spec batches.
The solid dose facility was previously inspected in April 2016, when the FDA cited similar CGMP violations. According to the agency, promised remediation efforts were inadequate.
The FDA strongly recommended that Jubilant engage a consultant qualified to assist the drugmaker in meeting cGMP requirements.
Read the Warning Letter.