343, because they do not comply with the labeling requirements for dietary supplements as required by 21 CFR 101. Your Aloe, Vitamin C, Ginger, and Honey Syrup, Compuesto Vegetal Clasico Ladra Miller, Compuesto Vegetal Quisqueyano Syrup, Rabano Yodada with Noni and Vitamins, Rabano Yodado De "El Salvador," Apetol, Broncolito for Children, BroncoMiel Syrup, Bronkisan-Miel with Eucalyptus and Propolis, Compuesto Vegetal Clasico Ladra Miller, Collagen, Emulsion de Escocia Cherry Flavor, and Vino Carne Hierro products are misbranded dietary supplements under section 403 of the FD&C Act, 21 U.S.C. 342(g)(1), because we have identified serious violations of the Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements regulation, 21 CFR Part 111. In addition, your Rabano Yodada with Noni and Vitamins product is adulterated within the meaning of section 402(g)(1) of the FD&C Act, 21 U.S.C. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).īecause your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. Food and Drug Administration (FDA) inspected your drug and dietary supplement manufacturing facility, Pharmalab Enterprises, Inc., FEI 3004797270, at 3781 W 18th Ave., Hialeah, Florida, from May 29 to June 17, 2019. Issuing Office: Office of Pharmaceutical Quality Operations, Division II
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