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  5. Euphoria Fancy Food Inc. - 641801 - 11/21/2022
  1. Warning Letters

WARNING LETTER

Euphoria Fancy Food Inc. MARCS-CMS 641801 —

Delivery Method:
VIA EMAIL AND UNITED PARCEL SERVICE
Product:
Food & Beverages
Recipient:
Recipient Name
Vera K. Itzhakov
Recipient Title
President
Euphoria Fancy Food Inc.

149 2nd Ave
Brooklyn, NY 11215-4615
United States

Issuing Office:
Division of Northeast Imports

United States

WARNING LETTER

November 21, 2022

Re: CMS # 641801

Dear Ms. Vera K. Itzhakov:

On July 19 through August 4, 2022, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Euphoria Fancy Food Inc. located at 149 2nd Avenue, Brooklyn, NY 11215. We also conducted an inspection on August 13, 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. During our inspection, you stated you did not have FSVP records for any 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 emailed response dated August 5, 2022. In your email, you stated that you hired a consultant to come to your company on (b)(4) and help with your FSVP. You further stated that the factories you work with provided paperwork (b)(4) and you needed additional time to translate the documents. Your response did not include any documents or additional details regarding the information you said you obtained from your suppliers, as related to the FSVP requirements. Further, aside from stating the need to translate documents from your suppliers and meet with a consultant, you have not provided specific steps or actions you have taken or plan to take to come into compliance with the FSVP regulation. Our review of your response finds that you have not addressed the violations related to the food products you import. Specifically, you have not made any corrections or developed FSVPs for the foods you import in response to the Form FDA 483a issued on August 4, 2022. We acknowledged your response initially on August 17, 2022 and requested contact information for your consulting company and your timeline for compliance. We sent a follow-up email on August 24, 2022 and have not received a response from your firm to date.

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 any foods that you import, including the following foods:

  • Sandwich Spread imported from (b)(4)
  • Processed Cheese imported from (b)(4)
  • Biscuits Butter with Nuts imported from (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.

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)).

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# 641801 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/

Anna Alexander
Acting Program Division Director
Division of Northeast Imports

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