FDA WARNING_LETTER - SEI Pharmaceuticals, Inc. - September 29, 2011

On March 26, 2012, the FDA issued a Warning Letter to SEI Pharmaceuticals, Inc. following an inspection from September 19-29, 2011, at their Miami, Florida facility. 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 and follow written procedures for quality control operations (21 CFR 111.103). 2. Failure to verify finished dietary supplement batches met product specifications for identity, purity, strength, composition, and contamination limits (21 CFR 111.75(c)). 3. Failure to prepare and follow written Master Manufacturing Records (MMRs) for each unique formulation and batch size (21 CFR 111.205(a)). 4. Failure to prepare a batch production record for each manufactured batch (21 CFR 111.255(a)). 5. Failure to establish written procedures for laboratory operations and testing (21 CFR 111.303). 6. Failure to maintain, clean, and sanitize equipment, utensils, and contact surfaces, with observed residue on funnels