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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Raw Deal, Inc 10/4/12

  

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

Public Health Service
Food and Drug Administration
 

Central Region
Waterview Corporate Center
10 Waterview Blvd., 3rd Floor
Parsippany, NJ 07054

Telephone (973) 331-4908

October 4, 2012

 
WARNING LETTER
 
VIA UPS OVERIGHT
 
Mr. Barry I. Steinlight
President and Owner Raw Deal, Inc.
4 Gold Mine Road
Flanders, NJ 07836
 
File No: 13-NWJ-01
 
Dear Mr. Steinlight:
 
The United States Food and Drug Administration (FDA) inspected your facility located at 4 Gold Mine Road, Flanders, NJ 07836 on February 13 to March 8, 2012. During our inspection, you informed our investigators that your firm manufactures and sells the powdered mix products identified below to another firm that packages these products, without further processing, into retail packages as dietary supplements. You also informed our investigators that this firm produces labels for these products and affixes such labels to the products. You also provided our investigators with these product labels, which state that the products are "Nutritional Supplements" and include "Supplement Facts" panels. For these reasons, we evaluated whether these products were prepared, packed, or held under conditions that comply with the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements in Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111).
 
During the inspection, our investigators found serious violations of the dietary supplement CGMP regulations in 21 CFR, Part 111. These violations cause your 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 products have been prepared, packed, or held under conditions that do not meet current good manufacturing practice for dietary supplements.
 
However, this letter should not be interpreted to mean that FDA agrees with the characterization of the products as dietary supplements. In fact, the labels that you provided to our investigators for these products also describe the products as meal replacement products. Section 201 (ff)(2) of the Act [21 U.S.C. § 321 (ff)] states, in part, that the term dietary supplement means a product that "is not represented for use as a conventional food or as a sole item of a meal or the diet." If these products are labeled as dietary supplements, they cannot also be represented for use as meal replacements (i.e., sole items of a meal) because a product intended to replace a meal is not a dietary supplement. Such labeling would misbrand the products within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labeling would be false or misleading. Further, the introduction or delivery for introduction into interstate commerce, or causing thereof, of such misbranded products is prohibited under section 301(a) of the Act [21 U.S.C. § 331 (a)]. You can find the Act and FDA regulations through links in FDA's website at www.fda.gov.
 
The following violations were observed during the inspection:
 
Adulteration Violations
 
1. Your firm failed to conduct at least one appropriate test or examination to verify the identity of a dietary ingredient prior to its use, as required by 21 CFR 111.75(a)(1)(i).
 
Specifically, you did not conduct one appropriate test or examination to verify the identity of any of the dietary ingredients prior to using them in the manufacture of your "Mens Meal Replacement Blend" and "Woman Meal Replacement Blend" products (Lot Numbers MMRB-20110749, MMRB-9201108, MMRB-20110987, MMRB-2011067, WMRB-20110726, WMRB-20110916, WMRB-20110913, WMRB-20111024, and WMRB-20111118).
 
We received your written response to the FDA Form 483 dated March 19, 2012, which states that in the future your firm will conduct its own "testing on ingredients to be in compliance with GMP." This response is inadequate because you did not provide any documentation to support this correction, such as a standard operating procedure for identity testing or any results of tests or examinations conducted. Furthermore, you did not provide a timeframe as to the implementation of this proposed corrective action.
 
2. Your firm failed to verify that your finished "Mens Meal Replacement Blend" and "Woman Meal Replacement Blend" products met 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 these products, as required by 21 CFR 111.75(c). Specifically, you did not provide any documentation showing that your firm conducted any finished product testing to verify that established product specifications were met for your "Mens Meal Replacement Blend" and "Woman Meal Replacement Blend" products.
 
3. In your response dated March 19, 2012, you stated that your firm will no longer be manufacturing "Meal Replacement" blends and that your firm will conduct its own testing on every ingredient and blend that you manufacture; however, you did not provide details regarding when your firm will cease manufacturing these products or what your firm will do with finished products in stock. Further, you did not provide any documentation showing that your firm has begun verifying that your finished products meet 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 these products, as required by 21 CFR 111.75(c). We intend to assess the sufficiency of your corrections concerning this violation during our next inspection.
 
4. Your firm failed to prepare and follow a written master manufacturing record for your "Mens Meal Replacement" Blend and "Woman Meal Replacement Blend" products to ensure uniformity in the finished batch from batch to batch, as required by 21 CFR 111.205(a).
 
5. Your firm failed to prepare a batch production record every time you manufactured a batch of your "Mens Meal Replacement Blend" and "Woman Meal Replacement Blend" products, as required by 21 CFR 111.255(a). During the inspection, you did not provide any batch records for your "Mens Meal Replacement Blend" and "Woman Meal Replacement Blend" products.
 
In your response dated March 19, 2012 you provided batch production records for your EpiFem Daily Capsules (Lot# 1010091) and EpiFem Intimate Capsules (Lot #1010090); however, you did not submit batch production records for the lots of "Mens Meal Replacement Blend" and "Woman Meal Replacement Blend" products that were also cited in the FDA-483 issued to your firm. Instead, you stated that your firm will no longer be manufacturing "Meal Replacement" blends; however, you did not provide details regarding when your firm will cease manufacturing these products or what your firm will do with finished products in stock. We intend to assess the sufficiency of your corrections concerning this violation during our next inspection.
 
6. Your firm does not calibrate instruments or controls used in manufacturing or testing a component or dietary supplement to ensure the accuracy and precision of the instruments or controls, as required by 21 CFR 111.27(b). Specifically, the scales that you use to weigh ingredients for your finished Mens Meal Replacement Blend" and "Woman Meal Replacement Blend" products are not calibrated to ensure their accuracy and precision. The adequacy for use of these scales is determined by using a bag of an incoming ingredient of unverified weight.
 
Your March 19, 2012 response states that you will purchase weights, but you did not provide a timeframe regarding when you will purchase and begin using the new weights. We intend to assess the sufficiency of these corrections concerning this violation during our next inspection.
 
7. Your firm did not make and keep documentation of the date of use, maintenance, cleaning and sanitizing of equipment, as required by 21 CFR 111.35(b)(2). Specifically, you did not keep documentation of the date of use maintenance, cleaning and sanitizing of the (b)(4) Ribbon blender (b)(4) blender, (b)(4) mixers, and (b)(4) used to manufacture finished dietary supplements.
 
Your response dated March 19, 2012 states the following regarding this violation: warehouse supervisors will keep logs on the daily maintenance of each piece of equipment; you have provided warehouse supervisors with GMP guidelines that pertain to their daily functions; and supervisors will train the warehouse staff on GMP compliance. Your response is inadequate because you have not provided any documentation showing that your firm has started making and keeping daily logs of the date of use, maintenance, cleaning and sanitizing of equipment. Further, you failed to state when the training of warehouse staff is going to be conducted.
 
Misbranding Violations
 
Your "Mens Meal Replacement Blend" products are misbranded within the meaning of 403(w) of the Act [21 U.S.C. § 343(w)] because the label fails to declare the major food allergens, whey and soy as required by section 403(w)(1) of the Act.
 
Section 201 (qq) of the Act [21 U.S.C. 321 (qq)] defines milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well as any food ingredient that contains protein derived from one of these foods, with the exception of highly refined oils, as "major food allergens." A food is misbranded 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 adjacent to the list of ingredient, section 403(w)(1)(A) of the Act, [21 U.S.C. 343(w)(1)(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. "(wheat)"), except that the name of the food source is not required when either 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)(1)(B)].
 
Your "Mens Meal Replacement Blend" product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C §. 343(i)(2)] because it is fabricated from two or more ingredients and the labels fail to declare the common or usual name of each ingredient, as required under 21 CFR 101.4.
 
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. It is your responsibility to ensure that your firm and the products that you manufacture comply with the Act and FDA regulations.
 
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct the violations specified above may result in enforcement action without further notice, including seizure and injunction.
 
In addition, we note the following:
 
 
• The personnel engaged in manufacturing, packaging, and holding dietary supplements does not have the education, training, or experience to perform the person's assigned functions [21 CFR 111.12(c)]. Specifically, none of your personnel are trained in cGMP in Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements. In your response dated March 19, 2012, you stated that your firm conducted a meeting with supervisors and "all warehouse employees will be provided GMP Guidelines to follow." However, you did not provide documentation of this meeting and did not provide a copy of the GMP guidelines or a timeframe for their implementation.
 
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 non-compliance 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 reinspection fees (21 U.S.C. 379j-31(a)(2)(8)). 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 non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
 
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct the violations noted above, including an explanation of each step being taken to prevent their recurrence. Your response should include documentation of your corrective actions. If you cannot complete all corrective actions within fifteen working days, you should state the reason for the delay and the time within which you will complete the correction.
 
Your response should be addressed to U.S. Food and Drug Administration, 10 Waterview Boulevard, 3rd Floor, Parsippany, New Jersey, 07054, Attn: Kerry Kurdilla, Compliance Officer.
 
Sincerely,
/S/
Diana Amador-Taro
District Director
New Jersey District