Inspections, Compliance, Enforcement, and Criminal Investigations

NYSW Beverage Brands 1/7/15

  

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                                       

 

   January 7, 2015
 
WARNING LETTER NYK-2015-17 
 
 
VIA OVERNIGHT DELIVERY
DELIVERY SIGNATURE REQUESTED
 
Mr. Richard Zakka, President
NYSW Beverage Brands, Inc.
1458 Country Route 3
Halcott Center, NY 12430
 
Dear Mr. Zakka:
 
On June 4–25, 2014, an investigator with the U.S. Food and Drug Administration (FDA) inspected your facility located at 1458 Country Route 3, Halcott Center, NY.  Our inspection of your facility revealed that you failed to comply with the Current Good Manufacturing Practice (CGMP) regulations for Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, found in Title 21 of the Code of Federal Regulations, Part 111 (21 CFR Part 111). These violations cause your dietary supplement products including, but not limited to, “VBlast Acai Berry,” “VBlast Wildberry,” and “VBlast Tropical Punch” 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 CGMP requirements for dietary supplements. In addition, your “VBlast Tropical Punch,” “VBlast Gator Pit Energy Formula,” and “VBlast Pomegranate + Cherry,” products are misbranded under section 403 of the Act [21 U.S.C. § 343] because they do not comply with the FDA’s labeling regulations under 21 CFR Part 101.
 
However, this letter should not be interpreted to mean that FDA agrees with the characterization of your “VBlast Acai Berry,” “VBlast Wildberry,” “VBlast Tropical Punch,” “VBlast Gator Pit Energy Formula,” and “VBlast Pomegranate + Cherry” products as dietary supplements.  In fact, the labels for your “VBlast Acai Berry,” “VBlast Wildberry,” “VBlast Tropical Punch,” “VBlast Gator Pit Energy Formula,” and “VBlast Pomegranate + Cherry” products that we collected during our inspection revealed that these products are represented for use as conventional foods.[1] significant part of the entire daily drinking fluid intake of an average person in the United States. Finally, the products are packaged in a similar manner to other beverage products, such as vitamin waters.  Section 201(ff)(2) of the Act provides that dietary supplements do not include products represented for use as conventional foods [21 U.S.C. § 321(ff)(2)]. If your “VBlast Acai Berry,” “VBlast Wildberry,” “VBlast Tropical Punch,” “VBlast Gator Pit Energy Formula,” and “VBlast Pomegranate + Cherry” products are labeled as dietary supplements, they cannot also be represented for use as conventional foods because a product intended for use as a conventional food 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 The product labels bear “Supplement Facts” panels, however the words “water” and “punch” are used in the statements of identity for the products. In addition, according to your product labels, the 500 mL products are intended to be consumed in a single serving, which makes up a
prohibited under section 301(a) of the Act, 21 U.S.C. § 331(a). 
 
You may find the Act and the FDA’s regulations through links on FDA’s home page at www.fda.gov.
 
 Adulterated Dietary Supplements
 
To the extent you intend to market your products as dietary supplements, specific CGMP violations observed during the inspection include the following: 
 
1.    You failed to establish product specifications for each dietary supplement for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement to ensure the quality of the dietary supplement as required by 21 CFR 111.70(e).  Specifically, you did not establish specifications for the identity, purity, strength and composition of any of your various flavors of your finished product to ensure that each batch of product contains the levels of vitamins and minerals purported to be present based on the supplement facts information.
 
Once you have established specifications for products that you receive from a supplier for packaging or labeling as a dietary supplement,  you must verify that the specifications are met in accordance with 21 CFR 111.73 and 21 CFR 111.75(c), and you must make and keep records of such specifications in accordance with 21 CFR 111.95(b)(1).
 
Your response dated June 25, 2014 indicated that you receive the pre-batched syrup from your supplier, and provided specification sheets from the supplier. We note that while you do not manufacture the syrup, you are still responsible for establishing specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplement because you are the final product manufacturer. Reliance on the specification sheets provided by your supplier is insufficient to meet these requirements, and as such, your response is inadequate.
 
2.    You failed to establish identity specifications and component specifications that are necessary to ensure specifications for the purity, strength and composition of dietary supplements manufactured using the components are met, as required by 21 CFR 111.70(b)(1) and 111.70(b)(2). Specifically, your firm failed to establish identity, purity, strength and composition specifications for each of the components you use to manufacture your finished dietary supplement products.
 
Your response dated June 25, 2014 indicated that you receive the pre-batched syrup from your supplier and provided specification sheets obtained from the supplier. We note that while you do not manufacture the syrup, you are still responsible for establishing specifications for each component because you are the final product manufacturer. Reliance on the specification sheets provided by your supplier is insufficient to meet these requirements, and as such, your response is inadequate.
 
3.    Your firm failed to establish and follow written procedures for the responsibilities of the quality control operations as required by 21 CFR 111.103. Furthermore, your quality control personnel failed to ensure that your manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.105. Specifically, your quality control personnel failed to perform the following quality control operations:
  • Approving written procedures, and deviations from or modifications to them, that may affect the identity, purity, strength, or composition of a dietary supplement [21 CFR 111.105(a)];
  • Approving and releasing, or rejecting, each finished batch for distribution, including any reprocessed finished batch [21 CFR 111.123(a)(8)];
  • Material review and disposition decision [21 CFR 111.113];
  • Reviewing and approving decisions about whether to investigate a product complaint and reviewing and approving the findings and follow-up action of any investigation performed [21 CFR 111.135];
 
We acknowledge in your response dated June 25, 2014, you indicated that your Manufacturing and Material Flow Charts clearly outline step-by-step everything necessary for safe and accurate bottling. You also provided production records, a complaint log, and the document on (b)(4).”  However, because you did not provide documentation to address each of the quality control violations cited above (e.g., disposition decisions), we are unable to evaluate the adequacy of your response.
 
4.    You failed 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, as required by 21 CFR 111.205(a). Specifically, you do not have MMRs for any of the dietary supplements that you manufacture.
 
Your response dated June 25, 2014 provided Production Records, which included Production Orders that show a Bill of Materials, and indicated that you are weighing the vitamin syrup caps several times per day and recording the information at the QC Release step of the  vitamin syrup cap. Your response is inadequate because the Production Records that you provided are not master manufacturing records.
 
5.    Your firm failed to prepare a complete batch production record every time you manufactured a batch of dietary supplements, as required in 21 CFR 111.255(b). Specifically, the batch production records for your “VBlast Wildberry” (Batch #1009431581), “VBlast Acai Berry” (Batch 1009221511), and “VBlast Tropical Punch” (Batch #1009141501) failed to include the following information for a batch record, as required by 21 CFR 111.260:
  • The identity of equipment and processing lines used in producing the batch [21 CFR 111.260(b)];
  • The date and time of maintenance, cleaning, and sanitizing of the equipment and processing lines used in producing the batch, or a cross-reference to records, such as individual equipment logs, where this information is retained [21 CFR 111.260(c)];
  • A statement of actual yield and a statement of the percentage of theoretical yield at appropriate phases of processing [21 CFR 111.260(f)];
  • The actual results obtained during any monitoring operations, including weight checks [21 CFR 111.260(g)];
  • The results of any testing or examination performed during the batch production, or a cross-reference to such results, including visual inspection and measurements of bottles [21 CFR 111.260(h)];
  • Documentation, at the time of performance, of packaging and labeling operations, including an actual or representative label, or a cross reference to the actual location of the actual or representative label [21 CFR 111.260(k)].
We acknowledge in your response dated June 25, 2014, you indicated that the blow molding process does not need to be documented because the finished product is evaluated as a whole during the Retain/Receipt of the bottles. However, because you did not provide documentation of such evaluation, we are unable to evaluate the adequacy of your response. Additionally, your inventory transfer records do not show who performed the operations.
 
Further, even though you stated that only labels and packaging which are being used on the current “Production Order" are being picked for use, you are still required to maintain a representative label for each batch for your production records in accordance with 21 CFR 111.260(k)(2). We note that while you referred to a photograph of a designated marked area for the picked labels and packaging, we did not find this photograph in your response.
 
6.    Your firm failed to retain reserve samples for 1 year past the shelf life date or for 2 years from the date of distribution of the last batch of dietary supplements associated with the reserve sample, as required in 21 CFR 111.83(b)(3). Specifically, your samples of assembled bottles are only retained for approximately one month.
 
We acknowledge in your response dated June 25, 2014, you indicated that you will begin retaining (b)(4) bottles from each batch. However, your response is inadequate because you failed to provide information regarding how long you plan to retain these samples.
 
7.    Your firm failed to make and keep a written record of the findings of the investigation and follow-up action taken when an investigation is performed, as required by 21 CFR 111.570(b)(2)(ii)(F). Specifically, on June 25, 2014, you provided a copy of your (b)(4)but it failed to document the quality control decision to install a (b)(4) to your water treatment regimen to address product complaints relating to particulates found in your bottled water products.
 
8.    Your firm failed to make and keep documentation of training, including the date of the training, the type of training, and the person(s) trained, as required under 21 CFR 111.14(b)(2). Specifically, you told our investigator that your employees are trained on-the-job by your Plant Manager, but this training is not documented.
 
We acknowledge in your response dated June 25, 2014, you indicated that you intend to document training in the future. However, we cannot assess the adequacy of your response because you failed to provide any supporting documentation.
 
Misbranded Dietary Supplements
 
Your “VBlast Tropical Punch,” “VBlast Gator Pit Energy Formula,” and “VBlast Pomegranate + Cherry,” products are misbranded under section 403 of the Act [21 U.S.C. § 343] because they do not comply with the FDA’s labeling regulations under 21 CFR Part 101:
 
1.    Your “VBlast Tropical Punch,” “VBlast Gator Pit Energy Formula,” and “VBlast Pomegranate + Cherry” products are misbranded under section 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] in that the products do not include a statement of identity as a “dietary supplement” as required by 21 CFR 101.3(g).
 
2.    Your “VBlast Tropical Punch,” “VBlast Gator Pit Energy Formula,” and “VBlast Pomegranate + Cherry” products are misbranded within the meaning of section 403(k) of the Act [21 U.S.C. § 343(k)] because the products contain an artificial flavoring, coloring, or chemical preservative but do not bear labeling stating that fact. Specifically,
  • Your “VBlast Tropical Punch” fails to declare fruit juice concentrate (color) and caramel color in the product statement of ingredients. In accordance with 21 CFR 101.22(k), the label of a food to which coloring has been added shall declare the coloring in the statement of ingredients. 
  • Your “VBlast Gator Pit Energy Formula” product contains the chemical preservatives propylene glycol and Calcium Disodium Salt of EDTA (sequestrant), however it fails to bear labeling stating that fact in accordance with 21 CFR 101.22(j).
  • Your “VBlast Tropical Punch”  and “VBlast Pomegranate + Cherry” products contain the chemical preservative propylene glycol, however they fail to bear labeling stating that fact in accordance with 21 CFR 101.22(j).
In accordance with 21 CFR 101.22(j), a food to which a chemical preservative is added must bear a label declaration stating both the common or usual name of the ingredient and a separate description of its function. The following product labels fail to list the function of the chemical preservative ingredients:
  • Your “VBlast Tropical Punch” product label fails to list the function of the ingredient, sodium hexametaphosphate.
  • Your “VBlast Gator Pit Energy Formula” product label fails to list the function of the ingredients, sodium hexametaphosphate, sodium benzoate, and potassium sorbate.
  • Your “VBlast Pomegranate + Cherry” product label fails to list the function of the ingredient sodium hexametaphosphate.
3.    Your “VBlast Gator Pit Energy Formula” product is misbranded under 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 label fails to declare  an appropriate common or usual name of each ingredient, in accordance with 21 CFR 101.4 and 21 CFR 101.36. Specifically, the ingredient statement provided by your supplier listed the sub-ingredients DL-alpha-tocopheryl acetate and Vitamin A Palmitate, however they are not declared on the finished product label.
 
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence and the occurrence of other violations.  You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in enforcement action without further notice including, without limitation, seizure and/or injunction.
 
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 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 non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
 
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 corrective action within fifteen working days, state the reason for the delay and the date by which you will have completed the correction.
 
Your written response should be sent to Lillian C. Aveta, Compliance Officer, U.S. Food and Drug Administration, 158-15 Liberty Avenue, Jamaica, New York 11433. If you have any questions about this letter, please contact Compliance Officer Lillian C. Aveta at (718) 662-5576 or Email at Lillian.Aveta@fda.hhs.gov.
 
 
Sincerely yours,
/S/
Ronald M. Pace
District Director
New York District
 

[1] See “Guidance for Industry: Distinguishing Liquid Dietary Supplements from Beverages,” available at http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/ucm381189.htm

 

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