American Natural Products Inc – FDA Warning Letter, Sep 20, 2012

On May 2, 2013, the FDA issued a Warning Letter to American Natural Products, Inc., following an inspection from September 17-20, 2012, which found significant violations of Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111). These violations render their dietary supplement products adulterated under section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Failure to verify identity of dietary ingredients:** The company did not conduct identity testing for dietary ingredients in products like Milk Thistle and Artrimax batches, nor was an exemption granted. Their response, relying on supplier qualification, was deemed inadequate as it's not permitted for dietary ingredients. 2. **Failure to confirm identity of non-dietary ingredients:** The company did not test or qualify suppliers for non-dietary ingredients (e.g., rice in Milk Thistle and Artrimax), failing to meet specifications. Their response lacked documentation of a qualification program or timeline. 3. **Failure to establish specifications:** The firm lacked specifications for manufacturing processes, dietary ingredient components (identity, purity, strength, composition, contamination limits), labels, and packaging. Their response regarding future testing and equipment acquisition was inadequate, lacking documentation or timelines. 4. **Failure to establish Master Manufacturing Records (MMR):** The company