GM Manufacturing, Inc. – FDA Warning Letter, Feb 13, 2012

An FDA inspection of GM Manufacturing, Inc. from January 23 to February 13, 2012, revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111), causing products to be adulterated. Eight key deficiencies were identified. The firm failed to verify finished dietary supplement batches met specifications (21 CFR 111.75(c)) and did not conduct identity testing for dietary ingredient components prior to use (21 CFR 111.75(a)(1)(i)). Supplier qualification was inadequate, lacking COA reliability confirmation and documentation for non-dietary ingredients (21 CFR 111.75(a)(2)(ii)(A), (C)). Documentation failures included not preparing Master Manufacturing Records (MMRs) (21 CFR 111.205(a)) and Batch Production Records (BPRs) lacking complete information like batch numbers, equipment identity, cleaning dates, component details, and quality control approvals (21 CFR 111.255(b), 111.260). Operational issues involved inadequate segregation of manufacturing areas, leading to potential mix-ups (21 CFR 111.20(c)). The facility and equipment were not maintained in a clean and sanitary condition, with widespread powder residue (21 CFR 111.15(b)(1), 111.27(d)). Additionally, the firm lacked written procedures for quality control operations, including material review (21 CFR 111.103). The firm's responses to the FDA-483 were deemed inadequate. GM Manufacturing, Inc. must provide a written response within 15 days detailing specific corrective actions and preventative measures, with documentation. Failure to correct these violations may result in enforcement actions, including product seizure or injunction.