Primarch Manufacturing, Inc. – FDA Warning Letter, Aug 24, 2012

On March 5, 2013, the FDA issued a Warning Letter to Primarch Manufacturing, Inc. following an inspection from August 22-24, 2012. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111), rendering their products adulterated under section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Failure to establish specifications (21 CFR 111.70):** The company failed to establish identity, purity, strength, composition, contamination limits, labeling, packaging, and product specifications for any manufactured products. Their response, including SOPs, was inadequate as it lacked actual established specifications. 2. **Failure to verify component identity (21 CFR 111.75(a)(1)(i)):** The company did not conduct tests to verify the identity of dietary ingredients, specifically for "NO Holds N-O Fruit Punch, Lot (b)(4)". Their response, providing an SOP, was inadequate without documentation of actual testing. 3. **Failure to prepare and follow Master Manufacturing Records (MMRs) (21 CFR 111.205):** The company lacked MMRs for unique dietary supplement formulations and batch sizes. Their "manufacturing batch records" were not MMRs and lacked