FDA 483 - BPI Labs - March 10, 2022

BPI Labs in Evanston, WY, was inspected by the FDA from March 7-10, 2022, resulting in 12 observations. The inspection revealed significant deficiencies across production, quality, materials, laboratory, and packaging/labeling systems, indicating a lack of fundamental GMP controls. Issues included inadequate procedures for preventing contamination, deficient batch records, unvalidated equipment and processes, and a lack of quality unit oversight and employee training.