FDA 483 - Port Jervis Laboratories, Inc. - November 04, 2022

Port Jervis Laboratories, Inc., an OTC and Cosmetic Manufacturer in Port Jervis, NY, was cited with two observations during an FDA inspection. The firm failed to follow its quality control unit procedures regarding stability studies for manufactured batches. Additionally, the firm did not adhere to or write adequate procedures for instrument calibration, resulting in multiple overdue thermometers used for critical storage.