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WARNING LETTER

Kitchen Garden Foods, LTD MARCS-CMS 675168 —

Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
James P. Moinet
Recipient Title
Co-Owner and Director of Operations
Kitchen Garden Foods, LTD

Unit 15
Salmon Springs Trading Estate; Cheltenham Road Stroud
Gloucestershire
GL6 6NU
United Kingdom

Issuing Office:
Center for Food Safety and Applied Nutrition

United States

March 29,2024

WARNING LETTER 675168

Dear Mr. Moinet

The U.S. Food and Drug Administration (FDA) conducted an inspection of your acidified foods facility at Stroud, Gloucestershire GB from October 26 to 27, 2023. During that inspection we found that your firm had serious deviations from the Emergency Permit Control regulation (Title 21, Code of Federal Regulations, Part 108 (21 CFR Part 108) and the Acidified Foods regulation (21 CFR Part 114). At the conclusion of the inspection, the FDA investigator issued an FDA-483, Inspectional Observations that lists the observations made at your firm. We have not received a response to the FDA-483 from your firm.

As a manufacturer of acidified food products intended for export to the United States, you are required to comply with the Food, Drug and Cosmetic Act (the Act) and the regulations promulgated under the Act, including those relating to the processing of acidified food products. These regulations are described in 21 CFR Part 108, Emergency Permit Control and in 21 CFR Part 114, Acidified Foods. The Emergency Permit Control regulation was issued, in part, pursuant to section 404 of the Act (21 U.S.C. § 344). As outlined in the regulations, a commercial processor that does not adhere to all of the mandatory requirements of 21 CFR 108.25, and 21 CFR 114 could be subjected to an immediate application of the emergency permit control provisions of section 404 of the Act (21 U.S.C. 344). As stated in 21 CFR 108.25(j), for imported products, in lieu of issuing an order of determination that a permit is required before products from a commercial processor can be introduced into interstate commerce, FDA may take steps to refuse admission of the commercial processor's products under section 801 of the Act (21 U.S.C. 381) when offered for entry into the United States. Violation of the mandatory requirements set forth in 21 CFR 108.25, and 21 CFR 114 renders your acidified food products adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. 342(a)(4). You can find the Act and Acidified Food regulations through links in FDA’s home page at www.fda.gov.

Your significant observations are as follows:

1. Before packing any new product, your firm did not provide FDA with information on the scheduled process from a qualified process authority for your new acidified food as required by 21 CFR 108.25(c)(2). Specifically, as a commercial processor engaged in the thermal processing of acidified foods, you did not provide the FDA information as to the scheduled processes, including conditions for (b)(4) processing and control of (b)(4) and preservative level and source and date of the establishment of the process, for the following acidified food products: Onion Chutney (b)(4) oz., Fig Chutney (b)(4) oz., and Plum Chutney (b)(4) oz. We acknowledge that your firm obtained a new Food Canning Establishment (FCE) number on November 9, 2023; however, you have not filed any scheduled processes with the agency as required by the regulation.

2. Your firm’s personnel involved in (b)(4) control, (b)(4) treatment and critical factors of the operation were not under the operating supervision of a person who attended and satisfactorily completed a school approved by the FDA Commissioner, as required in 21 CFR 108.25(f). Specifically, upon requesting to review a certificate of completion for an employee who has attended a Better Process Control School, your firm stated no one has received this training or the equivalent.

3. Your firm’s containers are not marked with an identifying code specifying the establishment where the product was packed, year, date and packing period, as required by 21 CFR 114.80(b). Your current product coding system for your entire product line does not allow for positive identification of the product within each container or its date of manufacture. Specifically, on October 27, 2023, your production records titled “(b)(4)” indicate that your firm manufactured and packed on 10/17/2023 the Onion Chutney finished products marked with code “(b)(4) BEST BY 31.10.25. However, this code does not specify the establishment where the product was packed, the year, or the actual packing date.

You should respond in writing within (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. More specifically, your response should include documentation and information that would assist us in evaluating your corrections such as copies of your updated process filings and completed processing records demonstrating your firm’s ability to adhere to your scheduled process and monitoring of critical factors. 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. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

If you do not respond or if we find your response inadequate, we may take further action. For instance, we may take further action to refuse admission of your imported acidified food products under section 801(a) of the Act (21 U.S.C. § 381(a)), including placing them on detention without physical examination (DWPE). FDA’s DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA’s Import Alerts. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the acidified food regulations (21 CFR 108 and 114) is Import Alert #99-37 “Detention without Physical Examination of Low-Acid Canned Foods and Acidified Foods Without Filed Scheduled Processes”. This alert can be found on FDA’s web site at https://www.accessdata.fda.gov/cms_ia/importalert_1132.html.

This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and all applicable regulations, including the acidified food regulations (21 CFR Parts 108 and 114) and the CGMP & PC rule (21 CFR 117). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

Please send your reply to the Food and Drug Administration, Attention: Kari Batey, Compliance Officer, Food Adulteration Assessment Branch, Office of Compliance, Division of Enforcement, 5001 Campus Drive, College Park, MD 20740 U.S.A., or send via email at kari.batey@fda.hhs.gov. Please reference CMS No. 675168 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/

Ann M. Oxenham, J.D.
Director
Office of Compliance
Center for Food Safety
    and Applied Nutrition

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