FDA WARNING_LETTER - Milk Specialties Global - Wautoma - August 02, 2011

An FDA inspection of Milk Specialties Global's Wautoma, Wisconsin facility, conducted from July 27-29 and August 2, 2011, revealed serious violations of Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111). These violations render the firm's products adulterated under section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act. Key deficiencies included the failure to establish product specifications for identity, purity, strength, and composition of finished dietary supplement batches (21 CFR 111.70(e)), and the failure to determine if these specifications were met prior to distribution (21 CFR 111.73). The firm also failed to establish specifications for components used in manufacturing (21 CFR 111.70(b)(2)), and batch production records lacked complete information (21 CFR 111.255(b)). Furthermore, the company did not maintain documentation for material review and disposition decisions (21 CFR 111.140(b)(3)), and reserve samples were inadequate (21 CFR 111.83(b)(4)). The firm's August 19, 2011, response was deemed inadequate due to insufficient documentation of corrective actions. Milk Specialties Global is required to provide a written response within 15 working days detailing corrective actions and prevention measures, with potential enforcement actions like seizure or injunction for non-compliance.