FDA WARNING_LETTER - albert max inc. - May 28, 2013

The FDA issued a Warning Letter to Albert Max Inc., dba Vita Springs Health, following an inspection from May 9-28, 2013, at their Chino, CA facility. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111), rendering their products adulterated under section 402(g)(1) of the Act. Additionally, the firm's (b)(4) dietary supplement product was deemed an unapproved new drug under section 201(p) and misbranded under section 502(f)(1) due to therapeutic claims like "Supports the treatment of chronic diseases" and "Reduces bad cholesterol (LDL)," and a lack of adequate directions for use. CGMP violations included failure to verify the identity of dietary ingredients (21 CFR 111.75(a)(1)(i)), establish component specifications (21 CFR 111.70(b)), ensure scientifically valid test methods (21 CFR 111.75(h)(1)), prepare and follow Master Manufacturing Records (21 CFR 111.205(a)), and quality control personnel failing to ensure product quality and proper packaging/labeling (21 CFR 111.105). The firm's responses were deemed inadequate for several issues. Furthermore, the (b)(4) product was also cited as a misbranded dietary supplement under section 403 of the Act for failing to list the manufacturer's place of business (21 CFR 101.5), identify the plant part for an ingredient (21 CFR 101.4(h)(1)), and bear the common or usual name of ingredients in its proprietary blend (21 CFR 101.4). The FDA requires prompt corrective action within 15 working days, with documentation, to prevent further enforcement actions like product seizure or injunctions, and potential re-inspection fees.