FDA WARNING_LETTER - Theta Brothers Sports Nutrition, Inc. - November 08, 2011

On October 11-November 8, 2011, an FDA inspection of Theta Brothers Sports Nutrition, Inc. dba Protein Factory in Lakewood, NJ, revealed significant Current Good Manufacturing Practice (CGMP) violations for dietary supplements (21 CFR Part 111), rendering their products adulterated.

Key violations include: 1. **Inadequate Equipment Cleaning:** Failure to clean equipment between production runs, leading to potential cross-contamination, especially with allergens like egg and milk. 2. **Lack of Finished Product Testing:** No verification that finished batches meet specifications for identity, purity, strength, and composition. 3. **Failure to Establish Specifications:** No established specifications for components or for the identity, purity, strength, and composition of several finished products (e.g., Rifle Protein Vanilla, PeptoPro Lemon Lime). 4. **Batch Production Record Deficiencies:** Failure to prepare BPRs for all batches (e.g., 100 custom orders in October 2011) and incomplete information in existing BPRs (e.g., missing unique identifiers, actual yield, initials, label reconciliation). 5. **Incomplete Master Manufacturing Records (MMRs):** MMRs lacked measures of dietary ingredients, leading to inconsistent adjustments during production. 6. **Inadequate Component Identification and Tracking:** Failure to establish procedures for identifying and tracking unique lots of components, and lack of unique identifiers for finished products in inventory