Triceutical Inc./Zhamg – FDA Warning Letter, May 29, 2012

The FDA inspected Triceutical Inc.'s dietary supplement manufacturing and packaging facilities in Farmingdale, NY, from May 16-29, 2012. The inspection revealed serious violations of FDA's Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111), rendering their dietary supplement products adulterated under section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. Failure to conduct identity testing for dietary ingredients prior to use for products like Joint King, Fiber Cleanse II, and various Protein Powders (21 CFR 111.75(a)(1)(i)). 2. Failure to verify that finished dietary supplement batches meet product specifications for identity, purity, strength, and composition (21 CFR 111.75(c)). 3. Master manufacturing records lacked required information, such as intentional overage amounts, theoretical yield statements, and representative labels (21 CFR 111.205(b)(2), 21 CFR 111.210). 4. Failure to prepare batch production records for manufactured dietary supplements (21 CFR 111.255(a), 21 CFR 111.260). 5. Quality control operations did not include approving/releasing or rejecting finished