WARNING LETTER
Thuan Thien Producing Trading Limited Company
MARCS-CMS 673718 —
March 29, 2024
Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Ms. Nguyen Thi Linh Trang
Recipient Title
Chief Executive Officer
Thuan Thien Producing Trading Limited Company
Lot 15, Street No 7, Tan Duc Industrial Zone
Duc Hoa Ha Village, Duc Hoa District
Long An City
Long An Province
Vietnam
thuanthienltd@gmail.com
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
March 29, 2024
WARNING LETTER
Reference No. 673718
Dear Ms. Nguyen Thi Linh Trang:
The United States Food and Drug Administration (FDA) conducted an inspection of your food manufacturing facility located at Lot 15, Street No 7, Tan Duc Industrial Zone, Duc Hoa Ha Village, Duc Hoa District, Long An City, Long An, Vietnam, from September 7 to September 8, 2023. Your firm manufactures a variety of juices, including Frozen Coconut Juice, Frozen Passion Fruit Juice, Frozen Pure Calamansi fruit, and Frozen Lime Juice. The inspection revealed serious deviations of the juice Hazard Analysis and Critical Control Point (HACCP) Systems regulation, Title 21, Code of Federal Regulations, Part 120 (21 CFR 120). At the conclusion of the inspection, the FDA investigator issued an FDA-483, Inspectional Observations, that lists the serious deviations found at your firm.
In accordance with 21 CFR 120.9, failure of a processor to have and implement a HACCP system that complies with 21 CFR 120.6, 120.7, and 120.8, or otherwise to operate in accordance with the requirements of Part 120, renders the juice products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug and Cosmetic Act (the Act), 21U.S.C. § 342(a)(4). Accordingly, your juice products, which are subject to the requirements of 21 CFR Part 120 are adulterated in that they may have been prepared, packed, or held under conditions whereby it may have been rendered injurious to health.
We received your responses to the FDA-483 via email on October 10, 2023, and November 3, 2023. Your responses included information regarding your 5-log reduction process for pathogen reduction and revising your HACCP plans for your juice products. After reviewing the inspectional findings and responses that your firm provided, we are issuing this letter to advise you of FDA’s concerns and provide detailed information describing the findings at your facility. Your significant violation is as follows:
You must include in your HACCP plan control measures that will consistently produce, at a minimum, a 5-log reduction, for a period at least as long as the shelf life of the product when stored under normal and moderate abuse conditions, in the pertinent microorganism, to comply with 21 CFR 120.24(a).
Specifically, your HACCP plans for Frozen Passion Fruit Juice, Frozen Pure Calamansi fruit, and Frozen Lime Juice identify
(b)(4)
treatment to achieve a 5-log reduction of pertinent microorganisms in your juice products. However, you have not provided documentation to demonstrate the identified control measures will consistently produce a 5-log reduction of the pertinent microorganisms in each juice you produce. The inactivation of microorganisms by
(b)(4)
depends on various factors (the transmissivity of the product, number of solid particles and suspended materials, the geometric configuration of the reactor, wavelength and physical arrangement of the
(b)(4)
source(s), the product flow rate, type of microorganisms and their growth phase, and initial microbial density.
In your response, you state you are using scientific literature to support that the
(b)(4)
process has been validated. However, the referenced article does not cover the specific juice products you are producing. You must have data to demonstrate the
(b)(4)
process you are using is valid for your specific juice products, including equipment validation and process validation. In your response to this letter, you should provide information demonstrating the equipment has been validated for its intended use, including complete details regarding the operation of the equipment, data to demonstrate the equipment operates as intended, and produces the required monitoring documentation. Further, you should provide data demonstrating the efficacy of the proposed treatment for each of the juices you produce (i.e., the treatment will repeatedly and reliably produce the required microbial reduction).
Furthermore, your Frozen Coconut Juice is a low-acid juice product, and
Clostridium botulinum
is the pertinent microorganism. Bacterial endospores, including Bacillus and Clostridium species, are known to be highly resistant to various forms of radiation including
(b)(4)
. Accordingly, your proposal to treat your coconut juice with
(b)(4)
is not adequate to produce the minimum 5-log reduction in the pertinent microorganism (
Clostridium botulinum
), as required by 21 CFR 120.24(a).
This letter may not list all the violations at your facility. You are responsible for ensuring that your facility operates in compliance with the Act and all applicable regulations. You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations. If you do not believe your products are in violation of the Act, include your reasoning and any supporting information for our consideration.
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. Responding in English will help to assist us in our review of your documentation.
If you do not respond or if we find your response inadequate, we may take further action. For instance, we may take action to refuse admission of your juice products under Section 801(a) of the Act (21 U.S.C. § 381(a)), including subjecting it to 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. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the juice HACCP regulation is Import Alert #20-07. You may view this alert at: https://www.accessdata.fda.gov/cms_ia/importalert_761.html.
Please send your reply to the Food and Drug Administration, Attention: Victoria Wagoner, Compliance Officer, Office of Compliance, Division of Enforcement, Food Assessment and Adulteration Branch (HFS-607), 5001 Campus Drive, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Victoria Wagoner via email at Victoria.Wagoner@fda.hhs.gov. Please reference 673718 on any submissions and within the subject line of any emails to us.
Sincerely,
/S/
Ann Oxenham, J.D.
Director
Office of Compliance
Center for Food Safety
and Applied Nutrition
Content current as of:
04/02/2024
Regulated Product(s)
Food & Beverages