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

The FDA issued a Warning Letter to Bell International Laboratories, Inc. following an inspection from September 11-19, 2023, identifying significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include: 1. **Inadequate Quality Unit (QU):** The firm failed to establish an adequate QU with written and followed procedures (21 CFR 211.22(a) and (d)). The QU lacked control over OTC drug manufacturing, failed to ensure adequate procedures, and did not ensure thorough investigations with root cause, CAPA, and effectiveness checks. Missing production and laboratory records from 2021-2022 were noted. The response was inadequate as it didn't address ensuring complete investigations, impact of missing records on marketed products, or maintaining record accuracy. 2. **Failure to Test Components:** The firm failed to adequately test samples of each component for identity and conformity, specifically lacking a limit test for diethylene glycol (DEG) and ethylene glycol (EG) on all glycerin lots (21 CFR 211.84(d)(1)). This was a repeat observation from a June 2017 inspection. The response was inadequate due to lack of specificity on testing plans and failure to conduct a retrospective risk assessment for products on the market. 3. **Inadequate Production and Process Control Procedures:** The firm failed