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  5. Ethnic Specialties, Inc. dba Darbar Foods - 607520 - 06/03/2020
  1. Warning Letters

WARNING LETTER

Ethnic Specialties, Inc. dba Darbar Foods MARCS-CMS 607520 —

Delivery Method:
VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Amir Bickiya
Ethnic Specialties, Inc. dba Darbar Foods

1907 S Quaker Ridge Pl.
Ontario, CA 91761-8041
United States

Issuing Office:
Division of West Coast Imports

United States

WARNING LETTER

June 3, 2020

Re:  CMS # 607520

Dear Mr. Amir Bickiya:

On April 3, 2020, the Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) inspection at Ethnic Specialties, Inc. dba Darbar Foods, located at 1907 S Quaker Ridge Pl., Ontario, CA 91761.  We also conducted an inspection on August 23, 2018. These inspections were conducted to determine your 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 have been produced in a manner that meets applicable U.S. food safety standards.  You will 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-supplierverification-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 your Frozen Sheermal and Mezban Potato Samosa imported from (b)(4).  Your firm did not have FSVPs for these products.  Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.

At the conclusion of both the initial FSVP inspection on August 23, 2018 and the follow-up inspection on April 3, 2020, our investigator provided you with Form FDA 483a, FSVP Observations.  

We have not received your response to either FDA 483a.

Your significant violations of the FSVP regulations 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, your firm did not develop an FSVP for Frozen Sheermal ((b)(4)) and Mezban Potato Samosa ((b)(4)) manufactured by (b)(4).

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.  

You should take prompt action to correct the above violations.  If you do not promptly correct these violations, 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 Frozen Sheermal and Mezban Potato Samosa manufactured by (b)(4).  We may place these foods from the identified foreign suppliers on detention without physical examination (DWPE) when you import these products.  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.

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 these 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 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: David Serrano, Compliance Officer, Division of West Coast Imports, One World Trade Center, Suite 300, Long Beach, CA 90831.  If you have any questions regarding this letter, you may contact Mr. Serrano via email at: david.serrano@fda.hhs.gov.  Please reference CMS # 607520 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/
Dan R. Solis
Program Division Director
Division of West Coast Imports 

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