FDA WARNING_LETTER - M.D.R. Fitness Corp. - August 03, 2012

An FDA inspection of M.D.R. Fitness Corp. from July 23 to August 3, 2012, revealed non-compliance with Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111), rendering their repackaged products adulterated under Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act. Additionally, an October 2012 review of the firm's website, www.mdr.com, found that products such as Artery Factors, Cardio Tone, Cranberry Concentrate, Fitness Tabs for Men, and Longevit-E are promoted with therapeutic claims (e.g., lowering blood pressure, improving prostate health, cancer protection) that cause them to be unapproved new drugs under Sections 201(g)(1)(B) and 201(p) of the Act, requiring prior FDA approval under Section 505(a). Specific CGMP violations included the failure to establish written procedures for maintaining, cleaning, and sanitizing equipment (21 CFR 111.35(b)(1)(iii)) and the failure to document equipment use, maintenance, cleaning, and sanitizing (21 CFR 111.35(b)(2)). The firm's August 14, 2012, response to the Form FDA 483 was deemed inadequate. M.D.R. Fitness Corp. must promptly correct all violations, investigate their causes, and prevent recurrence. A written response detailing corrective actions and a timeframe is required within fifteen working days. Failure to comply may result in legal action, including seizure or injunction, and the assessment of reinspection-related fees.