FDA WARNING_LETTER - Vita-Herb Nutriceuticals, Inc. - June 29, 2010

On October 20, 2010, the FDA issued a Warning Letter to Vita-Herb Nutriceuticals, Inc. following an inspection from May 18 to June 29, 2010. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) for dietary supplements (21 CFR Part 111), rendering products like Cod Liver Oil, Bombyx Mori, and Omega-3 DHA capsules adulterated under Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act.

Key deficiencies included: 1. **Failure to test finished batches:** The firm did not test finished batches of dietary supplements (e.g., Cod Liver Oil, Bombyx Mori, Omega-3 DHA capsules) for identity, purity, strength, and composition as required by 21 CFR 111.75(c). The firm's response was deemed inadequate for lacking documentation of past testing or future plans. 2. **Failure to verify dietary ingredient identity:** The firm did not conduct identity testing on dietary ingredients (e.g., cod liver oil, bombyx mori proprietary blend, DHA oil) prior to use, as required by 21 CFR 111.75(a)(1)(i). Microbiological tests performed were insufficient for identity verification. The firm's response was inadequate. 3. **Failure to