WARNING LETTER
G.N.R. Group Co., LTD.
MARCS-CMS 679766 —
April 17, 2024
Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Ritz Chalermchaicharn
Recipient Title
General Manager
G.N.R. Group Co., LTD.
273 Rama 3 Soi 53, Rama 3 Rd
Yan Nawa
Bangkok
10120
Thailand
info@gnrgroup.co.th
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
April 17, 2024
WARNING LETTER
Reference No. 679766
Dear Mr. Chalermchaicharn:
The United States Food and Drug Administration (FDA) conducted an inspection of your food manufacturing facility located at 273 Rama 3 Soi 53, Rama 3 Rd, Yan Nawa, Bangkok Thailand 10120 from January 22 to January 23, 2024. Your firm manufactures a frozen fruits, vegetables, and coconut 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 email response to the FDA-483 on February 6, 2024, and address the details of your response below. Based on our review of the inspectional findings and the response that your firm provided, we are issuing this letter to advise you of FDA’s concerns and to 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, as required by 21 CFR 120.24(a).
Specifically, your HACCP plan for Frozen Coconut Juice lists the critical limits for pasteurization of
(b)(4)
degrees Celsius for
(b)(4)
seconds at two critical control points: “
(b)(4)
” and “
(b)(4)
” to control pathogenic bacteria. However, your Frozen Coconut Juice is a low-acid juice product, and
Clostridium botulinum
is the pertinent microorganism. Your
(b)(4)
process for both the coconut meat and for the coconut water are not sufficient to produce a minimum 5-log reduction in non-proteolytic
Clostridium botulinum
(NPB), the pertinent microorganism. You have not provided documentation to demonstrate the identified control measures will consistently produce a 5-log reduction of the pertinent microorganisms in your Frozen Coconut Juice.
In your response, you cited the article, “Thermal Pasteurization of RTE Foods and Vegetables,” as support for your critical limits for the pasteurization (i.e.,
(b)(4)
process). However, we note that the article recognizes, “… for low-acid juices such as carrot juice, C. botulinum may be present and produce toxins, and therefore becomes the pathogen hazard of concern”. The article further states, “A severe pasteurization process of F90°C = 10.0 min aiming at a 6D process inactivation of nonproteolytic C. botulinum allows a product shelf life of up to 6 weeks at 5°C”. We recommend you engage with a process authority to develop a thermal process that will consistently produce a minimum 5-log reduction in non-proteolytic
Clostridium botulinum
(NPB). In your response to this letter, you should provide data demonstrating the efficacy of the proposed thermal treatment for Frozen Coconut Juice you produce (i.e., the treatment will repeatedly and reliably produce the required microbial reduction).
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.
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within fifteen (15) working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. 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 679766 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
Content current as of:
05/14/2024
Regulated Product(s)
Food & Beverages