WARNING LETTER

Gourmet & More MARCS-CMS 608887 — July 31, 2020

Delivery Method:: United Parcel Service
Product:: Food & Beverages

Recipient:: Recipient Name

Josiane N. Recollon; Recipient Title

Owner; Gourmet & More; 2976 Alvarado St., Ste D
San Leandro, CA 94577
United States

Issuing Office:: Division of West Coast Imports; United States

WARNING LETTER

July 31, 2020

Re: CMS # 608887

Dear Mrs. Josiane N. Recollon:

On May 28 and June 1, 2020, the Food and Drug Administration (FDA) conducted a remote Foreign Supplier Verification Program (FSVP) inspection at Gourmet and More, Inc. located at 2976 Alvarado St., Ste D, San Leandro, CA 94577. We also conducted an inspection on September 12, 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 your Brie Fermier Cheese imported (b)(4) in (b)(4) and Brillat-Savarin Affine cheese imported from (b)(4) in (b)(4). You 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 inspection and the follow-up inspection on May 28 and June 1, 2020, our investigator provided you in each instance with a Form FDA 483a, FSVP Observations.

We acknowledge receipt of your emails dated June 1, 2020 which included attachments related to your Brie Fermier and Brillat Savarin Affine cheeses. The documents included the following: (b)(4). However, we are unable to evaluate the adequacy of these documents because most of the documents have not been translated to English. In addition, you did not provide details as to how the documents meet the requirement of the FSVP regulation.

Your significant violation 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 of the foods you import, including the Brie Fermier Cheese imported from (b)(4), and Brillat-Savarin Affine imported from (b)(4) located in (b)(4), as required by section 805 of the FD&C Act and 21 CFR 1.502(a).

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.

(b)(3)(A)

As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are I compliance with the law.

(b)(3)(A)

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 the food products you import. We may place the foods you import on detention without physical examination (DWPE) when you import the products. You can find DWPE information relating to FSVP in Import Alert #99-41 at http://www.accessdata.fda.gov/cms_i a/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 revised 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). Please provide an English translation of any records that you provide in a language other than English in order to facilitate our review. 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: Debbie Giang, 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 Compliance Officer Giang via phone at (562) 256-9235 or via email at debbie.giang@fda.hhs.gov. Please reference CMS #608887 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 Solis
Program Division Director
Division of West Coast Imports