Nartex Laboratorios Homeopaticos S.A. de C.V. – FDA Warning Letter, Feb 28, 2020

The FDA issued a Warning Letter to Nartex Laboratorios Homeopaticos, S.A. de C.V., following an inspection from February 24-28, 2020, identifying significant CGMP violations for finished pharmaceuticals. The facility's methods, facilities, or controls render its drugs adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Failure to establish adequate written procedures for production and process control (21 CFR 211.100(a)):** The firm did not adequately validate manufacturing processes or qualify equipment for homeopathic drug products distributed to the U.S. While some validation documents were provided, the firm stated it would not validate all products due to lack of demand or discontinuation, which the FDA deemed inadequate, especially for products containing potentially toxic ingredients. The FDA requires a detailed summary of their validation program, a timeline for process performance qualification (PPQ), protocols, and a risk assessment for products remaining on the market. 2. **Failure to test samples of each component for conformity with specifications (21 CFR 211.84(d)(2)):** The firm relied on supplier Certificates of Analysis (COA) for purity, strength, and quality without adequate validation, only performing identity testing. The FDA found their response inadequate, requiring detailed plans for testing each component lot, or robust validation of