BEO Pharma Inc – FDA Warning Letter, Nov 4, 2024

On April 9, 2025, the FDA issued a Warning Letter to BEO Pharma Inc. dba BEO Pharmaceuticals Inc. following an inspection from October 16 to November 4, 2024. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Failure to test components:** The firm did not adequately test each component lot for identity, purity, strength, and quality, including active pharmaceutical ingredients (APIs) and high-risk components like (b)(4) and (b)(4) for diethylene glycol (DEG) or ethylene glycol (EG) contamination. They relied on supplier Certificates of Analysis (COAs) without validation. 2. **Inadequate Quality Unit (QU):** The QU approved drug product release (e.g., (b)(4) batch) before complete finished product testing, including microbial testing. Shipping products "Under Quarantine" is not permissible. The firm also failed to retain reserve samples of raw materials. 3. **Inadequate production and process controls:** Manufacturing processes for OTC drug products were not adequately validated prior to commercial distribution, with reports lacking sufficient detail or using outdated data. The (b)(4) water system was not adequately designed, controlled, maintained, or monitored. 4