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  5. Key Foods Co. dba Key Food Services - 683671 - 06/27/2024
  1. Warning Letters

WARNING LETTER

Key Foods Co. dba Key Food Services MARCS-CMS 683671 —

Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Hannett S. Gee
Recipient Title
Chief Executive Officer
Key Foods Co. dba Key Food Services

3701 W 128th Place
Alsip, IL 60803-1514
United States

Issuing Office:
Division of Northern Border Imports

United States

Secondary Issuing Offices

United States

June 27, 2024

WARNING LETTER

Re: CMS # 683671

Dear Mr. Hannett S. Gee:

From April 11 through April 25, 2024, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Key Foods Co. dba Key Food Services located at 3701 W 128th Place, Alsip, IL 60803-1514. We also conducted an inspection from April 3, 2023, through April 17, 2023. 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 FSMA Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals | FDA

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. 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 response dated May 6, 2024. Your response stated your intent to take FSPCA/FSVP training with Registrar Corp., and then to develop FSVP plans for your imported food products. We are unable to evaluate the adequacy of any corrective actions because you have not provided any supporting documentation demonstrating your planned or completed corrective actions. To date, no additional FSVP documents have been received by FDA.

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:

  • Oliang Powder Mixed (Café Gu Cua Thai Lan) imported from (b)(4), located in (b)(4)
  • Rice Stick Noodles imported from (b)(4), located in (b)(4)
  • Thai Hom-Mali Rice imported from (b)(4), located in (b)(4)
  • Coconut Milk (b)(4) manufactured by (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. 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 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 you delay and state when you will correct any remaining violations.

Please send your reply to Food and Drug Administration, Attention: Joseph DiNardo, Compliance Officer, Division of Northern Border Imports. If you have any questions regarding this letter, you may contact Compliance Officer DiNardo via email at joseph.dinardo@fda.hhs.gov. Please reference CMS #683671 on any documents or records you provide to us and on the subject line of any email correspondence you send to us.

Sincerely,
/S/

Keith J. Jasukaitis
Program Division Director
Division of Northern Border Import

CMS Case # 683671

Mr. Hannett S. Gee, Chief Executive Officer
Key Foods Co. dba Key Food Services
4130 S Morgan St.
Chicago, IL 60609-2515
312-225-0225
hgee@keyfoodservices.com

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