FDA 483 - International Trading Pharm Lab Inc - September 21, 2023

International Trading Pharm Lab Inc, a control testing lab in Paterson, NJ, was cited for significant deficiencies in laboratory controls and data integrity during an FDA inspection. Observations included inadequate method verification, insufficient computer system controls with broad administrator access, failure to investigate discrepancies, and non-functional data loggers for stability monitoring. These issues indicate a lack of assurance in the quality and reliability of drug product testing and data.