FDA WARNING_LETTER - Total Health Advanced Nutrition, Inc. - November 03, 2014

An FDA inspection of Total Health Advanced Nutrition, Inc. conducted on October 28-29 and November 3, 2014, identified significant violations of Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111). The firm manufactures and distributes dietary supplements, including EDTA Oral Chelation Nuvi-Detox and Nuvi-JointRx, which are deemed adulterated under section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act due to these CGMP failures. Key deficiencies include the failure to establish product specifications for finished batches (EDTA Oral Chelation Nuvi-Detox) and for received products (Nuvi-JointRx), as well as component specifications for identity, purity, strength, and contamination limits. The firm also lacked written master manufacturing records and batch production records for EDTA Oral Chelation Nuvi-Detox. Significant quality system issues were noted, such as the absence of written procedures for quality control operations, including material review and disposition, and the failure to designate a person responsible for quality control. Further violations involved the lack of a comprehensive system for production and process controls, insufficient documentation of manufacturing history for Nuvi-JointRx, and the absence of written procedures for holding, distribution, packaging, labeling, and product complaint handling. The firm's written response dated November 7, 2014, was deemed inadequate as it lacked supporting documentation for corrective actions. Total Health Advanced Nutrition, Inc. must provide a written response within 15 working days detailing specific corrective steps and supporting documentation to prevent recurrence, or face potential regulatory actions like seizure, injunction, and re-inspection fees.