Pristine Bay LLC – FDA Warning Letter, Sep 17, 2012

The FDA conducted inspections at two facilities of the dietary supplement manufacturer, located at 1661 Waycross Rd. and 7165 E. Kemper Rd., Cincinnati, OH, on August 28 – September 17, 2012, and August 28, 2012, respectively. The inspections revealed significant violations of the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111), rendering products like "Enzyte," "Ogoplex," and "Avlimil Complete" adulterated under Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act).

Key violations include: 1. **Failure to establish specifications:** The firm failed to establish finished product specifications for identity, purity, strength, composition, and contamination limits for its dietary supplements, as required by 21 CFR 111.70(a) and (e). This was a repeat violation from a 2010 inspection. 2. **Failure to implement quality control operations:** The firm did not perform quality control operations, lacked designated quality control personnel, and failed to identify a person responsible for quality control, violating 21 CFR 111.65 and 111.12(b). Written procedures for material review and disposition were not established (21 CFR 11