FDA WARNING_LETTER - Cohere Beauty - November 30, 2023

The FDA inspected Health Specialty's drug manufacturing facility in Santa Fe Springs, California, from November 27-30, 2023, identifying significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated.

Key violations include: 1. **Failure to establish adequate written procedures for production and process control (21 CFR 211.100(a))**: The firm failed to validate the manufacturing processes for their OTC drug product (b)(4), having distributed at least (b)(4) lots in 2023 without demonstrating consistent quality. Their response was inadequate, lacking assurance for released batches and a plan for stability monitoring or complaint handling. 2. **Quality control unit failure (21 CFR 211.22)**: The Quality Unit (QU) lacked adequate oversight to ensure drug products complied with CGMP and met specifications.

The FDA noted inadequate quality systems and a history of similar CGMP observations from a December 2022 inspection, indicating insufficient executive management oversight. The firm committed to ceasing drug production. If manufacturing resumes, Health Specialty must notify the FDA and engage a qualified consultant (21 CFR 211.34) to evaluate operations and perform a comprehensive six-system audit. The firm must respond within 15 working days, detailing corrective actions and prevention plans. Failure to address violations may result in regulatory action, including seizure,