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WARNING LETTER

Garden Fresh Market MARCS-CMS 614397 —


Delivery Method:
Via Express Delivery
Product:
Food & Beverages

Recipient:
Recipient Name
Golan Mor
Recipient Title
Owner
Garden Fresh Market

770 South Buffalo Grove Rd.
Buffalo Grove, IL 60089
United States

Issuing Office:
Division of Northern Border Imports

United States


August 4, 2021

WARNING LETTER

Re: CMS # 614397

Dear Mr. Golan Mor:

On March 22 through 30, 2021, the Food and Drug Administration conducted a remote Foreign Supplier Verification Program (FSVP) inspection of Garden Fresh Market located at 770 South Buffalo Grove Rd., Buffalo Grove, IL 60089. We also conducted an inspection on July 25, 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 Foreign Supplier Verification Program (FSVP) implementing 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-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 the pickled tomatoes, pickled tomatoes and cucumbers, and half sour pickles that you import from (b)(4), located in (b)(4). You did not have FSVPs for these products or for any foods that you import. 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 July 25, 2019, and the follow-up inspection on March 30, 2021, our investigator provided you in each instance with a Form FDA 483a, FSVP Observations. We acknowledge receipt of your responses dated September 10, 2019, and April 16, 2021, and we address your responses below.

On September 10, 2019, following the initial inspection, you stated that you were “not planning to import any product” at this time and would “[d]o all paper work” before importing again. We noted in response to your email that if your firm imports food, you must follow the pertinent FSVP requirements before importing the food. You continued to import food after September 10, 2019.

In your April 16, 2021 response to the most recent inspection, you stated that you will no longer buy direct from your foreign supplier (b)(4) in (b)(4) and will only use “local distributors.” We note that you made a similar statement in response to our initial 483a, FSVP Observations, issued on July 25, 2019, without making any corrections or developing an FSVP for the foods you imported. If you continue to import food from foreign suppliers, you must develop an FSVP for each of the foods you import.

Your significant violation of the FSVP regulation is 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 each of the following foods:
• Pickled tomatoes imported from (b)(4), located in (b)(4);
• Pickled tomatoes and cucumbers imported from (b)(4), located in (b)(4); and
• Half sour pickles imported from (b)(4), located in (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. Failure to adequately address this matter may result in 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 https://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 email your reply to Food and Drug Administration, Attention: Erica Koory, Compliance Officer, Division of Northern Border Imports, at erica.koory@fda.hhs.gov. Please reference CMS # 614397 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/

Sherea L. Dillon for Keith J. Jasukaitis
Program Division Director
Division of Northern Border Imports

 
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