FDA WARNING_LETTER - Advanced Nutritional Technology Inc. - May 14, 2012

On October 16, 2012, the FDA issued a Warning Letter to Advanced Nutritional Technology Inc. following an inspection from April 25 to May 14, 2012, at their Dublin, CA facility. The inspection revealed serious violations of Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111), rendering their products adulterated under 21 U.S.C. § 342(g)(1).

Key CGMP violations included: 1. Failure to package and label according to the Master Manufacturing Record (MMR) (21 CFR 111.415), specifically for Super EPA 2000, for which no MMR was provided. 2. Absence of established and followed written procedures for quality control operations, material review, disposition decisions, and reprocessing approval (21 CFR 111.103). 3. Failure to prepare batch production records for each batch of dietary supplements (21 CFR 111.255, 111.260), exemplified by the lack of a record for Super EPA 2000. 4. Lack of written procedures for handling received packaging and labels (21 CFR 111.153) and failure to keep required records (21 CFR 111.180(b