Victor Conte Jr.,
- SNAC System Inc.
1100 Industrial Rd Ste. 12
San Carlos, CA 94070
- Issuing Office:
- San Francisco District Office
| || |
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
Return Receipt Requested
February 27, 2017
Victor (NMI) Conte Jr., Chief Executive Officer
SNAC System, Inc.
1100 Industrial Rd Ste. 12
San Carlos, CA 94070
Dear Mr. Conte:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your dietary supplement facility, located at 1100 Industrial Rd Ste. 12, San Carlos, CA 94070 from August 15, 2016 through August 29, 2016. We found serious violations of the Current Good Manufacturing Practice (CGMP) regulations for Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). These violations cause your dietary supplement products identified below 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 the dietary supplements have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements.
Further, during the inspection of your facility, our investigator collected labels associated with many of your products. Based on our reviews, we have concluded that ZMA, Vitalyze, Super Citrimax, Aerobitine, ZMA-5, Hyp Oxygen, and Multi-Vitamins products are in violation of section 403 [21 U.S.C.
§ 343] of the Act, and the regulations implementing the food labeling requirements of the Act, which are found in 21 CFR Part 101. You may find the Act and FDA’s implementing regulations through links on FDA’s home page at www.fda.gov.
Dietary Supplements CGMPs
The inspection revealed the following significant violations of the CGMP requirements for the following dietary supplements:
1. ZMA, The Original Anabolic Mineral Support Formula, 90 capsules
2. ZMA, Nightcap Rapid Recovery Sleep Enhancer, 15.9 oz.
3. Vitalyze, Mental and Physical Performance Enhancer, 90 capsules
4. Proglycosyn Tubs, The Ultimate Post Workout Recovery Formula, 2.6 lbs.
5. Super Citrimax plus Chromate, Natural Weight Loss Formula, 90 capsules
6. Multi Vitamins Only, Vitamins A, C, E, D, B-complex, 60 capsules
7. Aerobitine, The Ultimate Anti-Fatigue/Fat Loss, 120 capsules
8. ZMA-5, The Next Generation Recovery and Sleep Enhancement, 90 capsules
9. Hypoxygen, The Oxygenation Enhancement Support Formula, 90 capsules
10. Xpedite, Performance Energy Drink Mix, 10.8 oz.
The following violations cause your dietary supplement products to be adulterated under section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions which do not meet the CGMP regulations for dietary supplements.
1. Your firm failed to meet the requirements for 21 CFR 111.73 which requires you to determine whether the established specifications are met in accordance with 21 CFR 111.75(c). Specifically, you provided during the inspection a COA for your HypOxygen product from your contract manufacturer Seven Manufacturing that shows “INPUT” as results for ingredient label claims. We find these results inadequate because “INPUT” is not a quantitative value achieved through testing which demonstrates that established specifications have been met.
2. You failed to establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, as required by 21 CFR 111.103. Additionally, once you have established your quality control procedure, you must implement quality control operations in your manufacturing, packaging, labeling, and holding operations for producing the dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.65.
Specifically, your quality control personnel failed to review and approve all specifications and finished product received from your contract manufacturers.
3. You failed to have all required records readily available during the retention period for inspection and copying by FDA when requested, as required by 21 CFR 111.610(a). Specifically, you were unable to provide a master manufacturing record for your SNAC brand dietary supplements products.
Misbranded Dietary Supplements
1. Your ZMA, Vitalyze, Super Citrimax, Aerobitine, ZMA-5, Hyp Oxygen, and Multi-Vitamins products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the products are fabricated from two or more ingredients, and each ingredient is not declared on the labels by the common or usual name, in accordance with 21 CFR 101.4 and 101.36. For example,
a. The ZMA, Vitalyze, Super Citrimax, Aerobitine, ZMA-5, and Hypoxygen product labels list “vegetarian capsule” in the “Other ingredients” list. Under 21 CFR 101.4(a)(1) and (g), the ingredients declared on the label of a dietary supplement in capsule form must include the ingredients forming the shell of the capsule.
b. Your Multi-Vitamins label indicates the ingredient “vegetarian” which is not the common or usual name of an ingredient.
The above violations are not intended to be an all-inclusive list of violations at your facility or that exist in connection with your products or their labeling. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that all the products you manufacture or distribute meet all of the requirements of the Act and its implementing regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, such as seizure and/or injunction.
We offer you the following labeling comments:
• Your Super Citrimax, Vitalyze, and Hypoxygen product supplement facts labels list (b)(2)- and (b)(3)-dietary ingredients comingled within the same section of the supplement facts label. The listing of any (b)(3)-ingredients must follow a heavy bar that is placed below the last ((b)(2-dietary ingredient (if present)), in accordance with 21 CFR 101.36(e)(6).
• Your Super Citrimax product label lists “Chromate brand niacin-bound chromium” and Super Citrimax Brand…acid”. These phrases are intervening material per 21 CFR 101.2(e) and should be listed outside the nutrition information label.
• Your Super Citrimax product label fails to list each of the (b)(2)- and (b)(3)-dietary ingredients followed by the name of the source of the (b)(2)-dietary ingredient; for example, “Chrome Mate Chromium and Super Citrimax (Garcinia Cambogia) are incorrectly listed. Likewise, in your ZMA-5 and Xpedite products, the listing of “Bioperine Black Pepper extract” should actually be “black pepper extract (Bioperine).
Please respond to this letter in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct the violations listed above and to prevent similar violations in the future. Your response should include any documentation necessary that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
Section 743 of the Act [21 U.S.C. 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection- related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
Your written response should be sent to Lawton W. Lum, Director of Compliance at the address noted above and reference unique identifier 509443. If you have any questions concerning this letter, please contact Compliance Officer Lance De Souza at (510) 337-6873.
Darla R. Brac y
Acting District Director
San Francisco District