Health Advances USA, Inc. – FDA Warning Letter, May 24, 2011

On October 17, 2011, the FDA issued a Warning Letter to Health Advances USA, Inc. following an inspection from May 16-24, 2011. The inspection revealed serious violations of Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111), rendering their products adulterated.

Key violations include: 1. Failure to establish and keep written procedures for manufacturing operations (21 CFR 111.353, 111.375). 2. Incomplete batch production records (BPRs), lacking equipment identity, actual/theoretical yield, and real-time documentation of component additions, packaging, labeling, and quality control approval (21 CFR 111.255(b), 111.260). 3. Failure to establish in-process specifications in Master Manufacturing Records (MMRs) for identity, purity, strength, and composition (21 CFR 111.70(c)(1)). 4. Failure to establish specifications for finished packaged and labeled dietary supplements (21 CFR 111.70(g)). 5. Quality control personnel failed to approve written procedures affecting product identity, purity, strength, or composition (21 CFR 111.105(a)). 6. Failure to quarantine packaging