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WARNING LETTER

VIA EMAIL AND UNITED PARCEL SERVICE
EXPRESS DELIVERY SIGNATURE REQUEST

    Re: CMS # 625478

Dear Mr. Zablotsky:

From November 23 to December 6, 2021, the U.S. Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Allure Foods LLC, located at 1542 45th Street, Brooklyn, NY 11219. We also conducted inspections on February 26, 2020, and August 27, 2018. 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 following foods you import: cashews imported from your foreign supplier (b)(4) – located in (b)(4) and roasted/salted fava beans and natural wasabi peas imported from your foreign supplier (b)(4) located in (b)(4). Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.

On November 11, 2021, when contacted for your availability for an FSVP inspection, you stated that you maintain your FSVP records onsite and that your FSVP records are in English. FDA sent a Form FDA 482d request for your FSVP records on November 23, 2021, and requested that you send your FSVP records to FDA “electronically or through another means that delivers the records promptly.” You did not respond to this request. At the conclusion of the inspection on December 6, 2021, you stated that you had FSVP records but that these records were with the individual handling the FSVP records for your firm. You stated that you would provide the records within 15 business days. Our investigator provided you with a Form FDA 483a, FSVP Observations on December 6, 2021. To date, we have not received your response to the Form FDA 483a or any FSVP records. Based on your inconsistent responses regarding the location of your FSVP records and your failure to provide any FSVP records, we have no alternative but to conclude that you lack FSVP records.

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 an FSVP for cashews imported from your foreign supplier (b)(4) located in (b)(4); and roasted/salted fava beans and Natural wasabi peas imported from your foreign supplier (b)(4), located in (b)(4).

Alternatively, to the extent that you have any FSVP records, you failed to send your records to FDA electronically or through another means that delivers the records promptly, in response to FDA’s written request, as required by section 805(d) of the FD&C Act and 21 CFR 1.510(b)(3).

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 from the identified foreign suppliers 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)). 

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: Feryal Ahmad, Compliance Officer, Division of Northeast, ORAOEIONEIMPORTSWLResponses@fda.hhs.gov. Please also cc (carbon copy) Feryal.Ahmad@fda.hhs.gov. If you have any questions regarding this letter, you may contact Compliance Officer Ahmad via email at Feryal.Ahmad@fda.hhs.gov. Please reference CMS# 625478 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