Warning Letter For Herbal Nitro Inc. 9/22/11
October 11th, 2011 // 1:25 pm @ jmpickett
Mr. Dante Spano, President
Herbal Nitro Inc.
Yucaipa, CA 92399
Dear Mr. Spano:
On May 3 through May 10, 2011, the U.S. Food and Drug Administration (FDA) inspected your dietary supplement firm located at 35133 Ravencrest Ct., Yucaipa, CA. During the inspection, you informed our investigators that your firm is an own-label dietary supplement distributor that enters into agreements with contract manufacturers to manufacture your dietary supplement products, and supplies such contract manufacturers with raw materials, including components used in the manufacture of your dietary supplement products. You also stated that these contract manufacturers are required to meet your firm’s dietary supplement formulations. As an own-label dietary supplement distributor that contracts with other manufacturers to manufacture dietary supplements that your firm releases for distribution under your firm’s name, FDA considers you to be a manufacturer of dietary supplements. As such, you have ultimate responsibility for the dietary supplements that you introduce or deliver for introduction into interstate commerce.
During the inspection, our investigators found that you have significant violations of the Current Good Manufacturing Practice (CGMP) regulation for Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111).
These violations cause your dietary supplement products to be adulterated within the meaning of Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not meet the CGMP regulations for dietary supplements in 21 CFR Part 111.
Your significant violations are as follows:
1. Your firm failed to establish specifications for identity, purity, strength, and composition for each component that you use in the manufacture of your dietary supplement products, as required by 21 CFR 111.70(b). Specifically, during the inspection, you told our investigators that your firm has not established any specifications for the components that your firm uses in the manufacture of your dietary supplement products. Your firm must establish specifications for the components it uses to manufacture a dietary supplement, regardless of whether your firm contracts with another firm to manufacture the components [See 72 Fed. Reg. 34752, 34843 (Jun. 25, 2007)].
2. Your firm failed to establish product specifications for the identity, purity, strength, and composition, and for limits on those types of contamination that may adulterate or that may lead to adulteration of your finished dietary supplements, as required by 21 CFR 111.70(e). Specifically, during the inspection, you told our investigators that your firm has not established finished product specifications for any of your dietary supplement products.
3. Your firm failed to verify that your finished dietary supplements met product specifications for identity, purity, strength, and composition, and for limits on those types of contamination that may adulterate or that may lead to adulteration of the finished dietary supplements, as required by 21 CFR 111.75(c). Specifically, you failed to verify that the following finished dietary supplements met product specifications for identity, purity, strength, and composition: (1) male libido enhancement capsules (lot (b)(4) ), and (2) alluraTRIM appetite suppressant capsules (lot (b)(4)) sold in 60ct bottles.
4. Your firm 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, your firm supplies it’s contract manufacturers with raw materials, including dietary ingredients. Your firm uses dietary ingredients, including (b)(4) Blend, (b)(4) Extract, and (b)(4) in your male libido supplement (Lot (b)(4)) and (b)(4)), (b)(4) and Proprietary blend, in your alluraTRIM appetite control Dietary Supplement. However, our investigators found that you did not conduct at least one test or examination to verify the identify of any of these dietary ingredients, as required by 21 CFR 111.75(a)(1). Instead, your firm relied on certificates of analysis (COAs) from your suppliers. A COA from a supplier may not be used to verify the identity of any component that is a dietary ingredient [21 CFR 111.75(a)]. You are required to conduct an appropriate test or examination to verify the identity of any component that is a dietary ingredient, unless you successfully petition FDA for an exemption from such testing [21 CFR 111.75(a)(1)].
5. Your firm failed to make and keep records of product distribution, as required by 21 CFR 111.475(b)(2). Specifically, during the inspection, our investigators observed that you failed to maintain records of distribution for all of your dietary supplements. Specifically, your firm was not able to account for approximately (b)(4) out of (b)(4) male libido capsules (lot (b)(4)) that your firm formulated and distributed.
