46 Hagley Park Road Kingston 10 Kingston Kingston Jamaica
Center for Food Safety and Applied Nutrition
5001 Campus Drive
College Park, MD 20740
NOV 16 2017
VIA EXPRESS DELIVERY
Naturefield Company Limited
46 Hagley Park Road Kingston 10
Kingston, JM-02, Jamaica
Reference # 538557
Dear Mr. Patrick Powell:
In response to arequest by the United States Food and Drug Administration (FDA) for a copy of your firm's HACCP documentation associated with the processing of your 100% coconut water, your U.S. agent provided your firm's HACCP plan entitled "NATUREFIELD COMPANY LIMITED HACCP PLAN" along with additional documentation sent via email on September 26, 2017. This request was prompted by information including data from our import entry database, that your firm routinely ships frozen 100% coconut water in retail packaging into the United States. Our review of your HACCP plan for your100% coconut water revealed a serious violation of the juice Hazard Analysis and Critical Control Point (HACCP) Systems regulation, Title 21, Code of Federal Regulations, Part 120 (21 CFR 120).
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), 21 U.S.C. § 342(a)(4). Accordingly, your 100% coconut water, a low-acid juice product, which is subject to the requirements of 21 CFR Part 120 is adulterated in that it may have been prepared, packed, or held under conditions whereby it may have been rendered injurious to health. You may find the Act, the juice HACCP regulation, the Juice HACCP Hazards and Controls Guidance, and the Refrigerated Carrot Juice and other Refrigerated Low-Acid Juices Guidance through links in FDA's homepage at www.fda.gov.
Your significant violation is as follows:
You must include in your HACCP plan control measures that will consistently produce, at a minimum, a S 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). However, your HACCP plan for 100% coconut water, a low-acid juice product, does not include control measures that will consistently produce a 5-log reduction of the pertinent microorganism, Clostridium botulinum.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should include documentation reflecting the changes you made, such as a copy of your revised juice HACCP plan for coconut water, five (5) consecutive days of completed monitoring records (i.e., records for the production of 5production date codes of the products) to demonstrate implementation of the plan, and any additional information that you wish to supply that provides assurance of your intent to fully comply now and inthe future with the applicablelaws and regulations. Submission of the information in English will assist in our review. 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 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 coconut water 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 where by products offered for import into the United States maybe 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 http://www.accessdata.fda.gov/cms_ia/importalert_761.html
This letter may not list all the violations at your facility. You are responsible for ensuring that you firm operates in compliance with the Act, the juice HACCP regulation (21 CFR 120), the CGMP regulation (21 CFR 110), and other applicable regulations. You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations.
Please send your reply to the U.S. Food and Drug Administration, Attention: Brandon Bridgman, Compliance Officer, Food Adulteration Assessment Branch, Division of Enforcement, Office of Compliance, Center for Food Safety and Applied Nutrition, HFS-607, 5001 Campus Drive, College Park, MD 20740 U.S.A. You may submit documentation accompanying your reply to: Brandon.Bridgman@fda. hhs.gov. Please include reference # 538557 on any submissions and within the subject line of any emails to us.