FDA 483 - PIC USA Inc - January 30, 2025

PIC USA Inc, a production facility in Adolphus, KY, was cited with three observations during an FDA inspection from January 28-30, 2025. The inspection revealed significant deficiencies in the firm's written procedures, particularly concerning the quality control unit, production and process controls, and labeling processes for drug products. These issues indicate a lack of adequate control over critical manufacturing operations.