JAMAICA, N.Y.—Confidence Inc., an own-label dietary supplement distributor that uses contract manufacturers to make its supplements, received a warning letter from FDA that said the company violated a number of the cGMPs (current good manufacturing practices), labeling requirements and other legal obligations.
During an inspection of Confidence’s Port Washington, NY, facility on Oct. 25 to 29, 2010 and on Nov. 2, 2010, Confidence said it does make its supplements; however, FDA said because Confidence distributes and markets its own supplements, the agency considers it to be a manufacturer and thus has responsibility for the dietary supplements that it sells.
FDA said it found “serious violations" related to manufacturing, packaging, labeling and holding operations for dietary supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). As a result, FDA said Confidence’s dietary supplement products are adulterated within the meaning of Section 402(g)(1) of the Federal Food, Drug and Cosmetic Act [21 U.S.C. § 343(g)(1)].
Specially, FDA said it found Confidence did not do the following cGMPs:
- Establish specifications for the gelatin capsules used in the manufacture of its dietary supplements, as required by 21 CFR 111.70(b).
- Establish specifications for its dietary supplement labels, as required by 21 CFR 111.70(d); during the inspection, FDA said it received partial specification sheets for Glucosamine Plus tablets, Full Bloom tablets, Modelslim capsules, Fe-Mon-9 capsules and pH Balance tablets. However, the specifications for these products did not include labeling specifications, as required by 21 CFR 111.70(d).
- Make and keep written procedures of quality control (QC) operations, as required by 21 CFR 111.103 and 21 CFR 111. 140(b)(1). FDA said manufacturers’ QC personnel must ensure that its manufacturing, packaging, labeling and holding operations ensure the quality of its dietary supplements and that its dietary supplements are packaged and labeled in accordance with established specifications, as required by 21 CFR 111.105 and 21 CFR 111.120(b).
- Establish written procedures for holding and distributing operations, as required by 21 CFR 111.453. The firm must hold components and dietary supplements under appropriate conditions of temperature, humidity and light so that the identity, purity, strength and composition of the components and dietary supplements are not affected [21 CFR 111.455(a)], according to FDA. Further, Confidence must hold components and dietary supplements under conditions that do not lead to the mix-up, contamination or deterioration of components and dietary supplements [21 CFR 111.455(c)].
- Collect and hold reserve samples of each lot of packaged and labeled dietary supplements that it distributes, as required by 21 CFR 111.83(a). These reserve samples must be identified with the appropriate batch or lot number for at least one year past the shelf life date (if shelf lift dating is used), or for two years from the date of distribution of the last batch [21 CFR 111.83((b)(2)-(3)].
