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WARNING LETTER
Reference #: CMS 678304

Dear Mr. Mitchell,

The U.S. Food and Drug Administration (FDA) conducted an inspection of your low-acid canned food (LACF) facility, located at The Creamery, Western Way, Melksham, Wiltshire, United Kingdom on October 30 & 31, 2023. The inspection revealed serious violations of the Emergency Permit Control Regulation [Title 21, Code of Federal Regulations, Part 108 (21 CFR Part 108)] and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers Regulation [Title 21, Code of Federal Regulations, Part 113 (21 CFR 113)]. At the conclusion of the inspection, an FDA-483, Inspectional Observations, was issued listing the serious deviations found at your firm. We acknowledge receipt of your responses, received via email on November 15, 2023, December 29, 2023, and February 1, 2024, which included corrective actions and supporting documentation taken by your firm in response to the observations noted on the FDA-483. Our evaluation of the documentation provided in your responses revealed that your responses were not adequate, as further described in this letter.

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Translation

As a manufacturer of LACF food products intended for export to the United States, you are required to comply with the Federal Food Drug and Cosmetic Act (the Act) and the Federal regulations relating to the processing of LACF foods. As outlined in the regulations, a commercial processor of LACF foods that does not adhere to all of the mandatory requirements of 21 CFR 108.35 and 21 CFR 113 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 108.35, for imported products, in lieu of issuing an order of determination that a permit is required before products from such 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. Violations of the mandatory requirements set forth in 21 CFR 108.35 and 21 CFR 113 renders your LACF CLOTTED CREAM products adulterated within the meaning of section 402(a)(4) of the Act (21 U.S.C. 342(a)(4)) in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You can find the Act and the LACF regulations through links in FDA's home page at www.fda.gov.

Your significant violations are as follows:

1. As a commercial processor engaged in the (b)(4) processing of low-acid foods packaged in hermetically sealed containers, you must process each low-acid food in each container size in conformity with at least the scheduled process, as required by 21 CFR 108.35 (c)(3)(i). Specifically, our investigator reviewed your scheduled processes for your 1 oz. (28 g) CLOTTED CREAM (HEAVY CREAM) (55% MILKFAT) and 6 oz. (170 g) CLOTTED CREAM (HEAVY CREAM) (55% MILKFAT) products, and noted the following deviations:
a. The scheduled process for your 1 oz. (28 g) CLOTTED CREAM (HEAVY CREAM) (55% MILKFAT) product identifies a process time of (b)(4) minutes at a processing temperature of (b)(4)°C ((b)(4)°F). However, on October 30, 2023, Lot #3303A was processed for (b)(4) minutes at (b)(4)°C, (b)(4) minutes below the time listed on your filed schedule process.

b. The scheduled process for your 6 oz. (170 g) CLOTTED CREAM (HEAVY CREAM) (55% MILKFAT) product identifies a process time of (b)(4) minutes and at a processing temperature of (b)(4)°C ((b)(4) °F). However, you informed our investigator that you process CLOTTED CREAM (HEAVY CREAM) (55% MILKFAT) packaged in 85g, 160g, and 170g glass jars for (b)(4) minutes at (b)(4)°C ((b)(4)°F), which is 4 degrees lower than the temperature listed on your filed schedule process.

These changes to your scheduled processes were made without the consultation of a process authority, nor did you file with the FDA an intentional change to your process schedules.

In your response email, dated December 29, 2023, you provided a Process Authority Report for your 6 oz. (170 g) and 1 oz. (28 g) CLOTTED CREAM (HEAVY CREAM) (55% MILKFAT) products, which you identified as a corrective action in your February 1, 2024, email. The email also described that you have increased the duration of the (b)(4) phases of your processes and reduced the duration of the (b)(4) phase by the same amount, and also provided master manufacturing records identifying updated manufacturing parameters including a hold time of (b)(4) minutes at (b)(4)°C for your 85 g, 160 g, and 170 g products, and a hold time of (b)(4) minutes at (b)(4)°C for your 28 g product. As required by 21 CFR 108.35(c)(2)(ii), if a packer intentionally makes a change in a previously filed scheduled process by reducing the initial temperature or retort temperature, reducing the time of processing, or changing the product formulation, the container, or any other condition basic to the adequacy of scheduled process, he shall prior to using such changed process obtain substantiation by qualified scientific authority as to its adequacy and notify the agency accordingly. To date, we have not received any new filings with the FDA for these products, or any requests to change your currently filed scheduled processes.

In addition to your Process Authority Report which summarizes validation studies undertaken by your firm regarding your 6 oz. (170 g) and 1 oz. (28 g) CLOTTED CREAM (HEAVY CREAM) (55% MILKFAT) products, you also attest in your February 1, 2024, email, that products received a process that renders them free of microorganisms, are therefore commercially sterile, and provide finished product testing results. However, your Process Authority Report did not demonstrate that products, as observed during the inspection, had been given a (b)(4) process that rendered them free of microorganisms of potential public health significance. Nor is it clear in your emailed responses, if product(s) were held pending review by your Process Authority, reprocessed according to parameters identified in your scheduled processes, or destroyed, as applicable, and as required by 21 CFR 113.89.

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 Emergency Permit Control regulation [Title 21, Code of Federal Regulations, Part 108 (21 CFR Part 108)], the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR Part 113), and the current Good Manufacturing Practice regulation (21 CFR Part 117).

You should respond in writing within fifteen (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, including processing records for five lots of product produced over at least five days. 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 LACF 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 LACF food regulations (21 CFR 108 and 113), is Import Alert #99-38, Detention without Physical Examination of Low-Acid Canned Foods and Acidified Foods Due to Inadequate Process Controls. This alert can be found on FDA's web site at https://www.accessdata.fda.gov/CMS_IA/importalert_1132.html.

Please send your reply to the Food and Drug Administration, Attention: Amy R. Glynn, 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 amy.glynn@fda.hhs.gov. Please reference CMS # 678304 on any submissions and within the subject line of any emails to us.

Sincerely,
/S/

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