Libby Laboratories, Inc. – FDA Warning Letter, Mar 14, 2025

On June 27, 2025, the FDA issued a Warning Letter to Libby Laboratories, Inc. following an inspection from March 11-14, 2025, at their Berkeley, California drug manufacturing facility. 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 conduct appropriate microbiological testing (21 CFR 211.165(b))**: Libby Laboratories released OTC sunscreen and antiseptic drug products, including one distributed to a children's hospital, without testing for objectionable microorganisms. Their response, claiming bactericidal ingredients negated the need for testing, was deemed inadequate, lacking scientific basis and retrospective testing. 2. **Failure to verify component identity and validate supplier analyses (21 CFR 211.84(d)(1) and 211.84(d)(2))**: The firm did not perform adequate identity testing for components like (b)(4) and (b)(4), relying on supplier Certificates of Analysis (COA) without validation. They also used grocery store-purchased (b)(4) with only organoleptic assessment, failing to use purified water and test high-risk components like (b)(4) and (b)(4) for hazardous impurities.