Vitaganic Inc. – FDA Warning Letter, Oct 13, 2011

The FDA conducted an inspection of Vitaganic Inc.'s dietary supplement manufacturing facility from September 9 through October 13, 2011, revealing significant 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 include the failure to verify finished product specifications for identity, purity, strength, composition, and contamination limits (21 CFR 111.75(c)), with the firm only weighing products instead of conducting appropriate tests. Vitaganic also failed to provide adequate documentation for in-process specifications, such as blending times (21 CFR 111.70(c)(2)). Furthermore, batch production records (BPRs) lacked complete information, including unique component identifiers, documentation of manufacturing steps (e.g., initials for weighing, verifying, and adding components), and quality control review/release (21 CFR 111.255(b), 111.260). Master manufacturing records (MMRs) were also deficient, missing complete component lists, intentional overage amounts, sampling procedures, and corrective action plans (21 CFR 111.210). Additionally, the firm used components in manufacturing before quality control operations determined their conformity to specifications and released them from quarantine, violating 21 CFR 111.120(b) and (e). The FDA deemed the firm's January 18, 2012, response inadequate due to a lack of supporting documentation. Vitaganic Inc. is required to take prompt corrective action and notify the FDA in writing within fifteen working days, providing specific steps, recurrence prevention measures, and supporting documentation to avoid potential legal action, including seizure and injunction.