FDA WARNING_LETTER - Revival Products, Inc. - February 12, 2020

The FDA conducted an inspection of a distribution facility in Kernersville, NC, from February 10-12, 2020, for food, dietary supplement, and cosmetic products. The inspection and subsequent label review revealed serious violations of the Federal Food, Drug, and Cosmetic Act.

The firm's dietary supplement products, including "Multivitamin Multimineral 100" and "gorgeous roses," were found to be adulterated under 21 U.S.C. § 342(g)(1) due to non-compliance with Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111). Specific violations included: 1. Failure to document quality control personnel review and approval for the release of packaged and labeled dietary supplements for distribution (21 CFR 111.140(b)(2)). For example, "Multivitamin Multimineral 100" COA listed "silica" but it was not on the label. 2. Failure to maintain adequate records for product complaints, with the complaint procedure not meeting requirements for documenting essential information like batch numbers, receipt dates, and investigation findings (21 CFR 111.570(b)). 3. Deficiencies in the written returned dietary supplement procedure, lacking requirements for material review, disposition decisions, and investigations of manufacturing processes if other batches are implicated (21 CFR