FDA 483 - Bell International Laboratories, Inc. - September 19, 2023

Bell International Laboratories, Inc. in Eagan, MN, a contract manufacturer of OTC drug products, was inspected by the FDA from 9/11/2023 to 9/19/2023. The inspection revealed significant deficiencies across quality control, laboratory operations, complaint handling, and record-keeping, indicating a systemic lack of adherence to cGMP regulations. These issues include inadequate product release testing, unvalidated methods, insufficient complaint investigations, and poor data integrity controls, posing potential risks to product quality and patient safety.