FDA 483 - Bell International Laboratories, Inc. - June 12, 2025

Bell International Laboratories, Inc. in Eagan, MN, was inspected by the FDA from June 2-12, 2025, for OTC drug manufacturing. The inspection revealed significant deficiencies across multiple areas, including raw material identity verification, inadequate investigation of out-of-specification results, and unvalidated manufacturing processes. Furthermore, severe data integrity issues, incomplete batch records, and a deficient supplier qualification program were observed, indicating a lack of robust quality control and adherence to GMP regulations.