FDA 483 - International Trading Pharm Lab Inc - October 29, 2019

International Trading Pharm Lab Inc, a control testing laboratory in Paterson, NJ, was cited for significant deficiencies in its quality control and data integrity practices during an FDA inspection. Observations included failures in OOS investigations, inadequate review of analytical data, insufficient computer system controls, and lack of method suitability verification. The firm also lacked proper employee training and equipment maintenance logs, with one observation being a repeat finding.