Vita Pure Inc – FDA Warning Letter, Mar 20, 2017

From March 2 to March 20, 2017, the FDA inspected Vita-Pure, Inc. in Roselle, New Jersey, revealing significant violations of 21 CFR Part 111, Current Good Manufacturing Practice (CGMP) for dietary supplements. These violations render the firm's dietary supplement products adulterated under Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Failure to establish finished product specifications (21 CFR 111.70(e)):** The firm lacked specifications for identity, purity, strength, composition, and contamination limits for finished dietary supplement batches. The Certificate of Analysis (C of A) for "Testosterone Wellness for Men" lacked required specifications, and the firm's reliance on "input" for test methods was deemed scientifically invalid. 2. **Failure to verify dietary ingredient identity (21 CFR 111.75(a)(1)(i)):** The firm's sole reliance on Fourier Transform Infrared Spectroscopy (FTIR) for identity testing of dietary ingredients was insufficient, as FTIR alone does not authenticate the ingredient's claimed identity. 3. **Failure to establish component specifications (21 CFR 111.70(b)(2)):** The firm lacked adequate component specifications for purity, strength, and composition. Reliance on organoleptic properties (color