| Public Health Service Food and Drug Administration |
Los Angeles District |
Department of Health and Human ServicesWARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
September 22, 2011
W/L 57-11
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.
This letter is not an all-inclusive list of violations at your facility. It is your responsibility to ensure that your establishment and your products comply with the Act and its implementing regulations. Failure to promptly correct the violations specified above may result in enforcement action without further notice. Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products.
In addition, we note the following:
• Your firm is required to prepare and follow a written master manufacturing record (MMR) for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch from batch to batch [21 CFR 111.205(a)]. Your MMR must identify specifications for the points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record [21 CFR 111.205(b)].
• Your firm includes expiration dates on the labels for your dietary supplement products, including your male libido capsules (lot (b)(4)) and your alluraTRIM capsules (lot (b)(4)) During the inspection, you informed our investigators that you did not conduct or have any data supporting the expiration dates listed on your product labels. Further, you stated that these dates are arbitrarily assigned based on product sales. Any expiration date you place on a product label should be supported by data that demonstrates the product’s shelf life [See 72 Fed. Reg. 34752, 34856 (Jun. 25, 2007).
Please advise this office in writing within 15 working days from your receipt of this letter of the specific steps you have taken to correct the violations noted above and to ensure that similar violations do not occur in the future. Your response should include any documentation necessary to show that the correction has been achieved. If you cannot complete all corrections before you respond, you should explain the reason for the delay and the date by which you will complete the corrections.
Your response should be sent to:
Blake Bevill
Director, Compliance Branch
Food and Drug Administration
Los Angeles District Office
19701 Fairchild
Irvine, CA 92612
Sincerely yours,
/s/
Alonza E. Cruse
District Director
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