FDA WARNING_LETTER - Vicare International (USA) INC. - March 01, 2017

On September 11, 2017, the FDA issued a Warning Letter to Vicare International (USA), Inc. following an inspection from February 22 to March 1, 2017, at their Alhambra, CA facility. The inspection revealed serious violations of Current Good Manufacturing Practice (CGMP) for dietary supplements (21 CFR Part 111), rendering their products adulterated under section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act.

As a distributor, Vicare International is ultimately responsible for ensuring all phases of dietary supplement production comply with CGMP requirements. Key violations included: 1. **Failure to establish finished product specifications (21 CFR 111.70(e))**: The firm failed to establish adequate specifications for identity and strength, and limits on contamination for finished dietary supplement batches. Their submitted specification sheets for products like "VI-DiabeCare" were inadequate, lacking sufficient acceptance criteria for identity and methods for strength testing. No revised specifications were provided for "Vicare Vi-Reishi," "NuLife Nu-Reishi," or "Vicare Super Cell." 2. **Failure to establish label and packaging specifications (21 CFR 111.70(d))**: The firm did not establish specifications for dietary supplement labels or packaging that contacts the supplements. The FDA could not evaluate the adequacy of their response as label and