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WARNING LETTER

Choo's Enterprises Ltd MARCS-CMS 683922 —


Delivery Method:
Via Express Delivery
Product:
Food & Beverages

Recipient:
Recipient Name
Edwin Cho
Recipient Title
CEO
Choo's Enterprises Ltd

Jordan's Complex
Eagle Hall, Saint Michael
Barbados

Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)

United States


WARNING LETTER

Reference # 683922

June 3, 2024

Dear Mr. Cho,

The United States Food and Drug Administration (FDA) conducted an inspection of your low acid and acidified foods facility, Choo's Enterprises Ltd, located at Jordan's Complex, Saint Michael, Barbados on March 4 through 6, 2024. 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 Acidified Foods regulation (21 CFR Part 114). At the conclusion of the inspection, a Form FDA 483 (FDA 483), Inspectional Observations, was issued listing the deviations found at your facility. We acknowledge receipt of your response received via email on April 4, 2024, which included a written response, a training record, and photographs. However, our evaluation of the documentation revealed that the response was not adequate, as further described in this letter.

As a manufacturer of acidified 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 acidified foods. The Emergency Permit Control regulations were issued, in part, pursuant to section 404 of the Act, Emergency Permit Control, 21 U.S.C. § 344. A temporary emergency permit may be required for acidified foods whenever a processor has failed to fulfill the requirements of 21 CFR 108.25, including registration and filing of process information, and the mandatory requirements in 21 CFR 114. Regulations specific to the processing of acidified food products are described in 21 CFR Part 108 and 21 CFR 114. As outlined in these 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) 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 acidified foods regulations through links in FDA’s home page at www.fda.gov.

Your significant deviations are as follows:

1. As a commercial processor of acidified foods, you must, not later than 60 days after registration and prior to the packing of a new product, provide the FDA information as to the scheduled processes, as required by 21 CFR 108.25(c)(2). For acidified foods, this information must include conditions for heat processing and control of pH, salt, sugar, and preservative level, and source and date of the establishment of the process, for each acidified food in each container size. Specifically, you do not have a scheduled process on file with FDA for products you have identified as acidified products, which include, but are not limited to, Windmill Baxter's Road Seasoning, Windmill Classic Mauby Syrup, Sweet & Tasty Mauby Syrup, Sugar Free Mauby Syrup, Ginger Beer Syrup, and Sugar Free Ginger Beer. Further, the scheduled process must be established by a qualified person who has expert knowledge acquired through appropriate training and experience in the acidification and processing of acidified foods, as required by 21 CFR 114.83.

Scheduled process information for acidified foods must be submitted on Form FDA 2541e a (Food Process Filing for Acidified Method). More information on registration and filing can be found in the publication "Guidance for Industry: Submitting Form FDA 2541 (Food Canning Establishment Registration) and Forms FDA 2541d, FDA 2541e, FDA 2541f, and FDA 2541g (Food Process Filing Forms) to FDA in Electronic or Paper Format'' available at: http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/ucm309376.htm.

Your response stated “(b)(4).” You further stated that you are consulting with a process authority. However, your response did not address whether you plan to file a scheduled process for your acidified food products. You will be unable to offer acidified food products for entry into the United States without scheduled processes on file with FDA.

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 foods regulations (21 CFR Parts 108 and 114) and the Current Good Manufacturing Practice regulation (21 CFR Part 117, Subpart B). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

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 foods regulations (21 CFR Parts 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.

Additionally, we offer the following comment:

  • Your firm’s operators of processing and packaging systems are not under the operating supervisions of a person who has attended and satisfactorily completed a school approved by the FDA for pH controls and critical factors in acidification. Although your response indicated that you will be having your Food Safety and Quality Assurance Officer take an online acidified foods manufacturing school, you did not provide any information on whether they have registered for the course or when they plan to take the course.

You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these deviations. More specifically, your response should include documentation and information that will assist us in evaluating your corrections such as evidence of submission of scheduled processes and any additional information that you wish to supply that provides assurance of your intent to fully comply now and in the future with the acidified foods regulations. 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 product is not in violation of the Act, include your reasoning and any supporting information for our consideration.

Please send your reply to the U.S. Food and Drug Administration, Attention: Sheena Phillips, Compliance Officer, Office of Compliance, Division of Enforcement, Food Adulteration and Assessment Branch (HFS-607), 5001 Campus Drive, College Park, Maryland 20740 U.S.A. If you have any questions regarding this letter, you may contact Ms. Phillips via email at Sheena.Phillips@fda.hhs.gov. Please reference CMS # 683922 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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