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

A routine surveillance Good Manufacturing Practice (GMP) inspection of Port Jervis Laboratories, Inc., an OTC drug and cosmetic manufacturer, was conducted by the FDA from October 31 to November 4, 2022. The inspection, performed under Compliance Program 7356.002, identified two main observations documented on an FDA Form 483. The first observation indicated that the responsibilities and procedures applicable to the quality control unit were not fully followed. Specifically, the firm failed to initiate a required stability study in 2021 for a powder foundation batch, contradicting its own established procedures (SOP 216) and falling short of regulatory expectations under 21 CFR 211.22(d). The second observation noted that procedures for the calibration of instruments, apparatus, gauges, and recording devices were either not adequately written or not followed. This was evidenced by uncalibrated thermometers found in critical storage equipment, including walk-in fridges used for APIs and raw materials. The inspection's conclusion resulted in the issuance of the FDA Form 483, highlighting these deviations from regulatory requirements. The company is now expected to address these findings with appropriate corrective and preventive actions.