FDA WARNING_LETTER - M.D. Science Lab - October 03, 2013

On July 15, 2014, the FDA issued a Warning Letter to M.D. Science Lab following an inspection from September 18 to October 3, 2013. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111), rendering their Max Load and Max Size Male Enhancement products adulterated.

Key violations included: 1. Failure to implement quality control operations and establish written procedures for quality control, material review, and disposition decisions (21 CFR 111.65, 111.103, 111.140(b)(1), 111.127(h), 111.140(b)(2)). The firm, as a distributor, is ultimately responsible for ensuring CGMP compliance, even with contract manufacturers. 2. Failure to establish specifications for packaging and labeling of finished dietary supplements (21 CFR 111.70(g)). 3. Failure to establish and follow written procedures for packaging and labeling operations, and to keep records of these procedures (21 CFR 111.403, 111.430(b)). 4. Failure to establish specifications for products received from suppliers for packaging/labeling to ensure proper identification and consistency with purchase orders (2