FDA WARNING_LETTER - james g. cole, inc. - March 23, 2012

The FDA conducted an inspection of James G. Cole, Inc. dba Maxam Nutraceutics' dietary supplement manufacturing facility in Hood River, Oregon, from March 20-23, 2012. The inspection revealed serious violations of Current Good Manufacturing Practice (CGMP) for dietary supplements (21 CFR Part 111), rendering the firm's products adulterated under section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act. A Form FDA 483 was issued, and the firm's subsequent responses were deemed inadequate due to insufficient detail and documentation of corrections. Significant violations included the failure to establish Master Manufacturing Records (21 CFR 111.205), failure to establish specifications for components (21 CFR 111.70(b)) and finished products (21 CFR 111.70(e)), and failure to verify the identity of dietary ingredients (21 CFR 111.75(a)(1)(i)). Additionally, the firm failed to identify quality control personnel and establish related written procedures (21 CFR 111.12(b), 111.103, 111.140(b)(1)), prepare complete Batch Production Records (21 CFR 111.255, 111.260), collect and hold reserve samples (21 CFR 111.83(a)), and establish procedures for returned dietary supplements (21 CFR 111.503, 111.535(b)(1)). The FDA requires prompt corrective action. Failure to comply may result in legal action, including seizure and injunction, and the assessment of re-inspection fees (21 U.S.C. 379j-31). The firm must provide a written response within 15 working days detailing specific corrective steps, recurrence prevention, and supporting documentation.