atlantic pro nutrients, inc. – FDA Warning Letter, Aug 1, 2011

On December 13, 2011, the FDA issued a Warning Letter to Atlantic Pro Nutrients, Inc. dba XYMOGEN following an inspection from July 18 to August 1, 2011. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) for dietary supplements (21 CFR Part 111), rendering their products adulterated.

Key violations included: 1. **Lack of Identified Quality Control Personnel:** The firm failed to identify individuals responsible for quality control operations, as required by 21 CFR 111.12(b). 2. **Inadequate Product Complaint System:** The firm did not have qualified personnel review all product complaints, nor did quality control personnel approve investigation decisions (21 CFR 111.560(a) and (b)). Records for product complaints were also not properly made and kept (21 CFR 111.570(b)(2)). 3. **Absence of Written Procedures for Holding and Distribution:** The firm lacked written procedures for holding and distributing operations (21 CFR 111.453), and the subsequently provided SOP QA-003 was inadequate, failing to address appropriate holding conditions (21 CFR 111.455(a)) and reserve sample protection (21 CFR 111.465). 4.