FDA WARNING_LETTER - Maximus Niterider International Group, Inc. - April 03, 2013

The FDA conducted an inspection of Maximus Niterider International Group, Inc.'s dietary supplement packaging and distribution facility from March 15, 2013, to April 3, 2013. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111), rendering products like Nite Rider and Pro-Male Quick Fix adulterated. Additionally, product labeling was found to be misbranded under section 403 of the Federal Food, Drug, and Cosmetic Act and 21 CFR Part 101. The firm's responses dated April 18 and June 26, 2013, were deemed inadequate. CGMP violations included failure to follow written quality control procedures (21 CFR 111.103, 111.105), failure to prepare and follow Master Manufacturing Records (21 CFR 111.205), and incomplete Batch Production Records (21 CFR 111.255(b)). Misbranding issues involved failure to declare the place of business (21 CFR 101.5), absence of a domestic address/phone for adverse event reporting (section 403(y)), non-compliant Supplement Facts panels (21 CFR 101.36, 101.4(g)), and failure to identify plant parts for ingredients (21 CFR 101.4(h)). The FDA emphasized the firm's ultimate responsibility for ensuring compliance, even with contracted manufacturing. The company must provide a written response within 15 working days detailing corrective actions, documentation, and a timetable for full compliance to avoid potential legal action and reinspection fees.