FDA Warns Nuvonyx of cGMP Violations

Nuvonyx failed to test AloeControl (batch # (b)(4)) and AloeAdvanced (batch # (b)(4)) dietary supplements to verify they met finished product specifications for identity, purity, strength and composition as required by 21 CFR 111.75(c). FDA found statements and the records provided to its investigator show that Nuvonyx performed (b)(4) tests on these batches of finished products, but this type of test does not verify the identity, purity, strength and composition of the finished product, as required by 21 CFR 111.75(c).

Nuvonyx did not establish component specifications for any components used in your AloeAdvanced and AloeControl dietary supplements, as required by 21 CFR 111.70(b)(1) and (b)(2. During FDAs October 2010 inspection, Nuvonyx indicated it would take corrective action by Jan. 1, 2011.  However, its January inspection revealed corrections were not made.

Nuvonyx failed to conduct at least one appropriate test or examination to verify the identity of a component that is a dietary ingredient, prior to its use, as required by 21 CFR 111.75(a)(1)(i). Specifically, the company uses dietary ingredients such as ecklonia cava kelp, gymnema sylvestre, and vitamin C in your AloeAdvanced Dietary Supplement and chromium piccolinate, coenzyme Q10 (Co10), pancreatin, conjugated linoleic acid, green tea and vitamin C in its AloeControl Dietary Supplement; however, FDAs investigator found the company did not conduct identity testing on any dietary ingredients, but instead relied on (b)(4) from your suppliers. (b)(4) from suppliers do not fulfill the requirements of 21 CFR 111.75(a)(1)(i) for dietary ingredients," FDA said it in warning letter. The regulations require you to conduct identity testing or examination for dietary ingredients."

Nuvonyx failed to qualify suppliers of components other than dietary ingredients by establishing the reliability of the suppliers certificate of analysis (CoA) through confirmation of the results of the suppliers tests or examinations, as required by 21 CFR 111.75(a)(2)(A).  Specifically, FDA found Nuvonyx sent (b)(4) to your suppliers who provide the company with a (b)(4) to validate" the use of the (b)(4).  However, FDA said this is inadequate because it does not show that Nuvonyx confirmed the results of the suppliers tests or examinations.

Nuvonyx failed to establish and follow written procedures for the responsibilities of the quality control (QC) operations, including written procedures for conducting a material review and making a disposition decision, and for approving or rejecting any reprocessing, as required by 21 CFR 111.103.

Lastly, FDA found Nuvonyx failed to make and keep records that show water, when used in a manner such that the water may become a component of the dietary supplement, meets the requirements of 21 CFR 111.15(e)(2), as required by 21 CFR 111.23(c).  Specifically, FDAs investigator found the company did not make records to show that the (b)(4) water used in its AloeAdvanced and AloeControl products complies with applicable federal, state and local requirements and does not contaminate the dietary supplements.