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  5. Dara Food LLC - 631229 - 05/31/2022
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WARNING LETTER

Dara Food LLC MARCS-CMS 631229 —

Delivery Method:
VIA EMAIL AND UNITED PARCEL SERVICE
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Namik Shakhpelangov
Recipient Title
President
Dara Food LLC

10 Commerce Road Unit 10D
Fairfield, NJ 07004-1602
United States

Issuing Office:
Division of Northeast Imports

United States

May 31, 2022

WARNING LETTER

Re: CMS # 631229

Dear Mr. Namik Shakhpelangov:

On February 17 – March 14, 2022, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Dara Food LLC located at 10 Commerce Road Unit 10D Fairfield, NJ 07004-1602. We also conducted an inspection on December 9, 2019. These inspections were conducted to determine compliance with the requirements of section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 384a) and the implementing FSVP regulation in 21 CFR part 1, subpart L.

The FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards. You may find information relating to the FSVP regulation and your responsibilities to comply with the regulation through links in FDA's FSVP web page at https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals.

During the most recent inspection, we found that you are not in compliance with the requirements of 21 CFR part 1, subpart L for the foods you import. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.

At the conclusion of the inspection, our investigator provided you with a Form FDA 483a FSVP Observations. We acknowledge receipt of your email dated March 30, 2022, which contained the FDA Form 482d, FSVP Records Identification Letter, and Form FDA 483a issued to you by FDA during your inspection. However, your email did not include any statements or documents describing any corrective actions you have taken or intend to make.

Your significant violations of the FSVP regulation are as follows:

You did not develop, maintain, and follow an FSVP as required by Section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, you did not develop, maintain, and follow an FSVP for any foods you import, including:

  • Confections (chocolate candy bar) imported from (b)(4)
  • Sheep’s milk cheese imported from (b)(4)
  • Baklava imported from (b)(4)

We acknowledge that during the inspection, you provided the investigator with the following documents:

  • For the confections you import from (b)(4), you provided a Health Certificate issued by the (b)(4), which states, “The producer/importer company of the product, which is intended to be exported by the exporter company, has been undergoing regular inspections of the Food Inspectors of (b)(4) in terms of minimum technical and hygienic requirements and related legislation and when necessary samples are taken from the products and analyzed by Authorized State Laboratories or Authorized Private Food Control Laboratories”; and a document titled “FSVP RECORD ITEM DETAILS” that provides information about the product, “Stick with chocolate, 400gr,” such as the ingredients, nutritional information, and organoleptic parameters.
  • For the sheep’s milk you import from (b)(4), you provided an International Veterinary Certificate of Origin and Health from the (b)(4), which provides information on the animal from which the product was derived.
  • For the baklava you import from (b)(4), you provided three Health Certificates issued by the (b)(4), which state, “The producer/importer company of the product, which is intended to be exported by the exporter company, has been undergoing regular inspections of the Food Inspectors of (b)(4) in terms of minimum technical and hygienic requirements and related legislation and when necessary samples are taken from the products and analyzed by Authorized State Laboratories or Authorized Private Food Control Laboratories”; and a document titled “FSVP RECORD ITEM DETAILS” that provides information about the product, “Frozen Baklava with Pistachio,” such as the ingredients, nutritional information, and organoleptic parameters.

You initially told the investigator that you thought the export certificates mentioned above were FSVPs. However, these documents do not constitute an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). As our investigator explained, the FSVP regulation generally requires that you conduct a written hazard analysis (21 CFR 1.504), evaluate your foreign supplier’s performance (21 CFR 1.505), and conduct foreign supplier verification activities (21 CFR 1.506), among other requirements. You responded that you do not have a hazard analysis, supplier evaluation procedures/activities, or verification procedures/activities. In addition, you stated you do not have an FSVP for any of the foods you import.

The above violations are not intended to be an all-inclusive list of violations of the FSVP requirements. It is your responsibility to ensure that you are in compliance with section 805 of the FD&C Act and the implementing regulation in 21 CFR part 1, subpart L.

This letter notifies you of our concerns and provides you an opportunity to address them. If you do not adequately address this matter, we may take further action. For instance, we may take action under section 801(a)(3) of the FD&C Act (21 U.S.C. 381(a)(3)) to refuse admission of the food you import for which you appear to be in violation of section 805. We may place the foods you import into the United States on detention without physical examination (DWPE) when you import the foods. You can find DWPE information relating to FSVP in Import Alert # 99 41 at http://www.accessdata.fda.gov/cms_ia/ialist.html. In addition, the importation or offering for importation into the United States of an article of food without the importer having an FSVP that meets the requirements of section 805 of the FD&C Act or the FSVP regulation is prohibited under section 301(zz) of the FD&C Act (21 U.S.C. 331(zz)).

In addition to the above violations, we also have the following comment:

We note that under 21 CFR 1.509, for each line entry of food product offered for importation into the United States, the FSVP importer must provide its name, electronic mail (i.e., email) address, and unique facility identifier (UFI) recognized as acceptable by FDA electronically when filing entry with U.S. Customs and Border Protection. The FSVP importer’s Data Universal Numbering System (DUNS) number is the UFI that is initially recognized as acceptable by FDA. DUNS numbers are assigned and managed by Dun & Bradstreet. You can find the Guidance for Industry: Compliance with Providing an Acceptable Unique Facility Identifier for the Foreign Supplier Verification Programs for Food Importers Regulation at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-compliance-providing-acceptable-unique-facility-identifier-foreign-supplier.

You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should address the specific things you are doing to correct any violations. You should include in your response documentation and information that would assist us in evaluating your corrections (e.g., documentation of changes you made, such as a copy of your FSVP, records to demonstrate implementation of your FSVP), and any additional information that you wish to supply relevant to your compliance with the FSVP regulation. If you believe that you are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete all corrections within 15 working days, you should explain the reason for your delay and state when you will correct any remaining violations.

Please send your reply to Food and Drug Administration, Attention: Linda Ross, Compliance Officer, Division of Northeast Imports, ORAOEIONEIMPORTSWLResponses@fda.hhs.gov. Please also cc (carbon copy) Linda.Ross@fda.hhs.gov. If you have any questions regarding this letter, you may contact Compliance Officer Ross via email at Linda.Ross@fda.hhs.gov. Please reference CMS# 631229 on any documents or records you provide to us and/ or within the subject line of any email correspondence you send to us.

Sincerely,
/S/

CAPT Nazmul Hassan
Program Division Director
Division of Northeast Imports

 
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