The FDA cited Impax Laboratories after an inspection revealed a significant discrepancy in the operational qualification of its packaging line’s tablet counter/elevator.
The agency issued a Form 483 after an August inspection of the firm’s Hayward, California, facility found broken tablets and half tablets, indicating a failure of the tablet counter and elevator.
The firm determined that the defects were not due to the filling process or equipment and it did not count the deficiencies in the list of total defects or document its investigation. As a result, the equipment was improperly listed as qualified for operation, the agency said.
The firm also failed to submit timely reports of serious adverse events to a business partner responsible for reporting AERs to the agency.