Dynamic Pharmaceuticals, Inc. – FDA Warning Letter, Dec 3, 2010

The FDA conducted an inspection of Dynamic Pharmaceuticals, Inc.'s dietary supplement manufacturing facility from November 20 to December 3, 2010, revealing significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111). Consequently, several of the firm's dietary supplement products were deemed adulterated under Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act. Key violations included the failure to verify finished batches meet product specifications for identity, purity, strength, and composition (21 CFR 111.75(c)), and the use of scientifically invalid methods for established specifications (21 CFR 111.320(b)). Batch production records (BPRs) were deficient, lacking unique component identifiers, weights, and proper documentation of manufacturing steps (21 CFR 111.260). Quality control personnel failed to conduct material reviews and make disposition decisions for out-of-specification products (21 CFR 111.113(a)(1)). Additionally, BPRs were incomplete and not accurately followed during production (21 CFR 111.255), and the firm lacked effective measures to protect against foreign material inclusion (21 CFR 111.365(i)). The investigator also noted a lack of product specifications for contamination limits (21 CFR 111.70(e)). The firm's December 14, 2010, response was deemed inadequate due to insufficient documentation of proposed corrective actions, such as updated SOPs, training records, or evidence of implementation. Dynamic Pharmaceuticals is required to provide a written response within 15 days detailing specific corrective steps and supporting documentation to avoid potential enforcement actions, including product seizure or injunction.