AG Hair Limited – FDA Warning Letter, Jun 24, 2022

On November 28, 2022, the FDA issued a Warning Letter to AG Hair Limited following an inspection from June 20-24, 2022, identifying significant Current Good Manufacturing Practice (CGMP) violations. The firm's drug products are deemed adulterated under 21 U.S.C. 351(a)(2)(B).

Violations include: 1. **Inadequate Investigations (21 CFR 211.192):** Failure to thoroughly investigate an elevated bioburden count in a water sample prior to manufacturing a drug product, and inadequate investigation of a customer complaint regarding skin irritation, relying solely on employee panel tests without further testing or root cause analysis. The firm's response to update SOPs was insufficient, lacking retrospective review of previous investigations and a comprehensive plan for CAPA. 2. **Inadequate Laboratory Controls (21 CFR 211.160(b)):** Failure to establish appropriate microbiological testing and specifications for all non-sterile drug products, specifically noting the lack of testing for "Hands Free Clean Hand Sanitizer Gel" and an inappropriate standard plate count specification for another product. The firm's commitment to update procedures was inadequate as it did not address previously distributed products. 3. **Inadequate Component Testing (21 CFR 211.84(d)(1) and 211.84(d