Marshalls Traditional Healthcare CC – FDA Warning Letter, Sep 23, 2024

On February 10, 2025, the FDA issued a Warning Letter to Marshalls Traditional Healthcare CC following an inspection from September 19-23, 2024. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug product adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Failure to conduct adequate finished product release testing (21 CFR 211.165(a) and 211.165(b))**: The firm failed to test the identity and strength of the active ingredient and for objectionable microorganisms for each batch of their OTC drug product. Their response was inadequate, lacking specific test details, risk assessment, or retrospective review of previously released products. 2. **Inadequate written procedures for production and process control (21 CFR 211.100(a) and 211.100(b))**: * **Inadequate Process Validation**: The firm lacked data to demonstrate validated manufacturing processes. Their process validation protocol was deficient, omitting operating parameters, bulk hold times, processing limits, and adequate sampling instructions. * **Inadequate Control of Water System**: The firm's water system was not suitable for drug manufacturing, being turned off when not in use and lacking adequate monitoring for chemical and