WARNING LETTER
Raya Green Coconut Co.
MARCS-CMS 684536 —
June 21, 2024
Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Wasan Jaemjaroon
Recipient Title
Managing Director
Raya Green Coconut Co.
Ltd.5/1 Moo 2. Phaeng Phuai
Damnoen Saduak
Ratchaburi
70130
Thailand
wasan.rygo@gmail.com
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
WARNING LETTER
Reference No. CMS 684536
Dear Mr. Jaemjarooon:
The United States Food and Drug Administration (FDA) conducted a remote regulatory assessment of your food manufacturing facility located at 5/1 Moo 2., Phaeng Phuai, Damnoen Saduak, Ratchaburi, 70130, Thailand, from March 11 to March 15, 2024. Your firm manufactures a variety of coconut products, including frozen coconut water (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 response to the FDA-483 via email on March 30, 2024. Your response included a quotation for conducting a temperature distribution and heat penetration study. After reviewing the inspectional findings and response 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. We also address your response below.
Your significant violation is as follows:
Your HACCP plan must, at a minimum, list all food hazards that are reasonably likely to occur, to comply with 21 CFR 120.8(b)(1). A food hazard is defined in 21 CF 120.3(g) as “any biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of its control.” However, your HACCP plan for your Frozen Coconut Water in Plastic Bag products does not list the food hazard of
Clostridium botulinum (C. botulinum)
, the pathogen public health significance in low-acid canned juices such as coconut water (juice).
In your response, you state you
(b)(4)
. You added that after you receive the test report that you will update the information with us as soon as possible. To date, we have not received any additional records regarding your corrective actions, including your revised HACCP plan. Your
(b)(4)
penetration and
(b)(4)
distribution studies are important for ensuring the proper delivery of your thermal process, which is applied to products in the final container in the firm’s custom retort. However, the thermal process appears to have not been properly developed. Your critical limits of
(b)(4)
°C (
(b)(4)
°F) for
(b)(4)
minutes are insufficient to produce a minimum 5-log reduction of C. botulinum, as required by 21 CFR 120.24(a). You have not provided any process validation data to support the process. Please refer to “PC Hazards Guide Appendix 4; Bacterial Pathogen Growth and Inactivation, Table A-4” for information regarding the inactivation of nonproteolytic C. botulinum.
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 684536 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:
06/25/2024
Regulated Product(s)
Food & Beverages