Inspections, Compliance, Enforcement, and Criminal Investigations

DNG Trading & Milling, LLC 10/21/14

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
New York District
158-15 Liberty Avenue
Jamaica, NY 11433

 

October 21, 2014
 
WARNING LETTER NYK-2015-4
 
 
VIA UNITED PARCEL SERVICE – Overnight Mail
 
Mr. David N. Gaon, CEO and Owner
DNG Trading & Milling, LLC
22 Brookville Road
Glen Head, NY 11545
 
-And-
 
Mr. James W. Mills, Executive Vice President
DNG Trading & Milling, LLC
4022 Mill Rd
Skaneateles, NY 13152-9319           
 
 
Dear Messer’s Gaon and Mills:
 
The U.S. Food and Drug Administration (FDA) inspected your dietary supplement manufacturing facility, located in Skaneateles, New York from November 20, 2013 through December 12, 2013. Our investigation found that you have serious violations of FDA’s Current Good Manufacturing Practice (CGMP) regulation for dietary supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). These violations cause the dietary supplement products you contract manufacture to be adulterated under Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §342(g)(1)] because they have been prepared, packed or held under conditions that do not meet the CGMP regulation for dietary supplements. Further, several of your products are misbranded under Section 403 of the Act (21 U.S.C. §343). You may find the Act and its implementing regulations through links on FDA’s home page at www.fda.gov.
 
Dietary Supplement Adulteration
 
On January 6, 2014 we received your response, dated January 3, 2014, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations issued to Mr. James W. Mills, Executive Vice President. We address the adequacy of this response below, in relation to each of the applicable violations. During our inspection of your facility, our investigator observed the following significant violations:
 
1.    Your firm failed to establish product specifications for the identity, purity, strength, and composition of the finished batches of your dietary supplements to ensure the quality of the dietary supplements, as required by 21 CFR 111.70(e). Specifically, you stated during the inspection that your firm does not have specifications established for the identity, purity, strength, and composition of your finished dietary supplements. For example, you have product specifications for the finished (b)(4) dietary supplement you manufacture; but these specifications include only physical specifications (for appearance, extraneous material, color, moisture, and product weight), microbiological specifications (for total plate count, total coliform, yeast, mold, Enterobacteriaceae, Pseudomonas aeruginasa, Staphylococcus aureus, E. coli, and Salmonella), and contaminant specifications (for arsenic, cadmium, lead, and mercury). These finished product specifications are inadequate because even if met, these specifications would not ensure the identity, purity, strength and composition of the product.
 
We received your response dated January 3, 2014, and found it to be inadequate. Although you state that product specifications for the identity, purity, strength, and composition of the finished dietary supplements you manufacture have been developed, you have not provided any supporting documented evidence of established finished product specifications for identity, purity, strength, and composition of the finished dietary supplements.
 
2.    You failed to conduct at least one appropriate, scientifically valid 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) and 111.75(h)(1). Specifically, your firm has not conducted appropriate, scientifically valid tests to verify the identity of any of the dietary ingredients used in the manufacturing of dietary supplements by your firm.
 
For example, your (b)(4) contain the dietary ingredient Tribulus Terrestris. However, your Raw Material Specifications sheet for this product only requires the visual inspection of the color of the received powder to confirm the identity of the ingredient.  This ingredient, which is a powder, cannot be identified through organoleptic testing. There is no ability to distinguish this ingredient from other powder ingredients through gross organoleptic analysis. Moreover, while color is an intrinsic property of an article, it is not exclusive to the article: many articles (or compounds) have the same color. Furthermore, a food color may be added to the article.  Therefore, while an incoming dietary ingredient of the wrong color could be excluded, an article of the same color is not substantiation of the identity, because as stated, many articles have the same color.  Moreover, an article could have the same color and still be rejected, if, for example, its spectroscopic data were not identical to a reference standard. Color cannot, therefore, be used as positive evidence of identity.
 
We received your response dated January 3, 2014, and found it to be inadequate. You state that identity testing of dietary ingredients is being performed on an as-needed basis prior to use in any dietary supplement products. “As needed” is not an adequate basis for identity testing. Furthermore, you have not addressed the appropriateness of your testing methods, nor have you provided any supporting documentation. 
 
3.    Your master manufacturing records (MMR) fail to meet the requirements of 21 CFR 111.210. Specifically, the records fail to contain:
 
a.    A statement of the expected minimum and maximum percentages of the theoretical yield of the finished dietary supplement beyond which a deviation investigation of a batch is necessary and material review is conducted and disposition decision is made [21 CFR 111.210(f)];
b.    A representative label, or a cross reference to the physical location of the actual or representative label [21 CFR 111.210(g)]; and,
c.    Procedures for sampling [21 CFR 111.210(h)(2)].
 
 
Your MMR for your (b)(4) did not include minimum or maximum percentages of the theoretical yield beyond which a deviation investigation is necessary, nor did it include procedures for sampling. Your MMR for this product did include a label; however, the label was outdated and therefore not representative of the product labels at the time of manufacture. 
 
We received your response dated January 3, 2014, and found it to be inadequate. Although you state that your MMRs have been changed to address these issues, you have not provided any supporting documentation, such as revised MMRs. We acknowledge receipt of your updated procedures regarding labeling controls and sampling procedures (SOP-QAM-008, SOP-QAM-003A, and SOP-WAR-003).
 
4.    Your operations for the batch production records failed to include reviewing and approving all batch production-related records as required by 21 CFR 111.123(a)(2). Specifically, your Quality Assurance Manager did not adequately review and approve all batch production records for your (b)(4) batches. For instance, the Formulation Batch Sheet, Batch Report, and Pre-Operational Encapsulation Check-sheet were not reviewed and signed by Quality Assurance after your firm conducted the relevant operations.
 
We received your response dated January 3, 2014, and found it to be inadequate. Although you have revised your procedure, SOP-QAM-011, and have provided this procedure for review, your firm did not provide evidence of how you are implementing these revised procedures, such as current batch records.
 
5.    You failed to perform each step in the appropriate MMR on the production of each batch, as required by 21 CFR 111.255(c). Specifically, your MMR for (b)(4) requires a ≥ 40 minute blend time; your batch production record (BPR) for Lot (b)(4) reveals that the product was only blended for what appears to be 24 minutes.
 
We received your response dated January 3, 2014, and found it to be inadequate. Although you have revised your procedure, SOP-QAM-011, and have provided this procedure for review, your firm did not provide evidence of how you are implementing these revised procedures, such as current batch records.
 
Dietary Supplement Misbranding
 
1.    Your (b)(4) and (b)(4) products are misbranded under Section 403(w) of the Act, [21 U.S.C.§ 343(w)], in that the finished product label fails to declare the known major allergen, milk, as specified in the Act.
 
Section 201 (qq) of the Act [21 U.S.C.§ 321 (qq)], defines "major food allergens" as milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts, and soybeans; as well as any food ingredient containing protein derived from one of these foods, with certain exceptions, e.g., highly refined oils derived from a major food allergen. A food is misbranded under section 403 (w) of the Act if it is not a raw agricultural commodity and it is, or it contains, an ingredient that bears or contains, a major food allergen, unless either:
 
  • The word "contains", followed by the name of the food source from which the major food allergen is derived, is printed immediately after or is adjacent to the list of ingredients, Section 403(w)(1)(A) of the Act [21 U.S.C. §343(w)(l)(A)]; or
  • The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived (e.g., "Whey (Milk)"), except the name of the food source is not required when whether the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen), Section 403(w)(1)(B) of the Act [21 U.S. C. §343(w)(l)(B)}.
 
Specifically, your (b)(4) label lists the ingredients: L-arginine, Ying Yang Hou, Chen PI, Chn, Yao, Renshen, Catauaba, Muira Puama, Rou Cong Dong, Wu Wei Zi, BioPerine®. However, the batch production records for
(b)(4) reveal it contains Whey Protein Concentrate 34% (a dairy allergen).
 
Specifically, the (b)(4) label lists the ingredients: Senna Leaf, Capsicum, Plantain Leaf, Xanthan Gum, Kelp, Gingko Leaf, Echinacea Purpurea Tops, Bromelain, Garlic Bulb, Ginger Root, Ginseng, Mate, Meadowsweet, St. John's Wort, and Valerian Root. However, the batch production record for (b)(4) reveals it contains Whey Protein Concentrate 34% (a dairy allergen).
 
2.    Your (b)(4) products are misbranded within the meaning of Section 403(e)(l) of the Act [21 U.S.C. §343(e)(l)] because they fail to list the place of business of the manufacturer, packer or distributor in accordance with 21 CFR 101.5.
 
3.    Your (b)(4) products are misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S. C.§ 343 (i)(2)] in that they are fabricated from two or more ingredients, and each ingredient is not declared on the label by the common or usual name, in accordance with 21 CFR 101.36 and 21 CFR 101.4. Specifically, your (b)(4) product label does not accurately contain the ingredients listed on the batch production record and doesn't list capsule ingredients.
 
4.    Your (b)(4) products are misbranded within the meaning of Section 403(q)(5)(F) of the Act [21 U.S.C.§343(q)(5)(F)] because the label fails to bear nutrition labeling in the proper format, which is required under 21 CFR 101.36.  For example, the nutrition information on your (b)(4) product lists ingredients in the wrong order in accordance with 21 CFR 101.36(b)(2)(i)(B).
 
5.    Your (b)(4) products are misbranded within the meaning of Section 403(s)(2)(B) of the Act [21 US.C. § 343 (s)(2)(B)] in that the label fails to identify the products using the term dietary supplement, in accordance with 21 CFR 101.3(g).
 
6.    Your (b)(4) product is misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 403 (q)(1)(A)] because the serving size declared on the label is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined by 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. For example the product label states a serving size of 1 capsule; however, the suggested usage states take 1 or 2 capsules 30 minutes before breakfast, lunch, and dinner with an eight ounce glass of water per capsule.
 
This letter may not list all the violations at your facility. You are responsible for ensuring that your facility operates in compliance with the Act and all applicable FDA regulations, including the CGMP regulation for dietary supplements. We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
 
You should respond 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 these violations. 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 re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a domestic facility, FDA will assess and collect fees for re-inspection-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 re-inspection-related costs.
 
Your written response should be sent the Food and Drug Administration; Attention:
 
LCDR Frank Verni, R.Ph.
Compliance Officer
U. S. Food and Drug Administration
158-15 Liberty Avenue, Room 4050
Jamaica, NY 11433
 
If you have any questions about the content of this letter please contact:  LCDR Verni at (718) 662-5702.
 
 
Sincerely,
/S/                                                                                   
Ronald M. Pace
District Director
New York District

Page Last Updated: 10/27/2014
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