Venus Pharmaceuticals International, Inc. – FDA Warning Letter, Aug 19, 2010

On August 16-19, 2010, the FDA inspected Venus Pharmaceuticals International, Inc.'s dietary supplement manufacturing and repacking facility in Hauppauge, NY, finding serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111). These violations render the firm's dietary supplements adulterated under Section 402(g)(1) of the Federal Food, Drug and Cosmetic Act.

Key violations include: 1. **Lack of Master Manufacturing Records (MMRs):** The firm failed to prepare and follow written MMRs for each unique formulation and batch size, as required by 21 CFR 111.205(a). Examples cited were Miracle Reds Blend, Super Fruits and Green, and Superior Joint Powder. The firm's submitted MMRs were inadequate, lacking complete component lists, accurate weights/measures, dietary ingredient identities, expected yields, and packaging/label descriptions (21 CFR 111.210). 2. **Incomplete Batch Production Records:** Batch records, such as for Miracle Reds Blend, Batch #1007004, lacked required information including equipment identity, unique component/packaging identifiers, and documentation of packaging/labeling operations (21 CFR 111.255(b), 111.260). Submitted records were not product-specific. 3.