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Rhodes Food Group Ltd. MARCS-CMS 538029 —

Food & Beverages

Recipient Name
Mr. Jurgens Bence
Recipient Title
Operations Manager
Rhodes Food Group Ltd.
Rhodes Food Group Ltd.

8 Industrial Street
Wellington, Western Cape
South Africa

Issuing Office:
Center for Food Safety and Applied Nutrition

United States

OCT 6, 2017



Mr. Jurgens Bence
Operations Manager
Rhodes Food Group (Pty) Ltd.
8 Industrial Street
Wellington, Western Cape, 7655 South Africa

Reference No.# 538029

Dear Mr. Bence:

The U.S. Food and Drug Administration (FDA) conducted an inspection of your juice processing facility, Rhodes Food Group (Pty) Ltd., located at 8 Industrial Street, Wellington, West Cape, South Africa on July 24 and 25, 2017. That inspection revealed serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 120. That inspection resulted in FDA's issuance of an FDA-483, Inspectional Observations, listing the deviations found at your firm at the conclusion of the inspection. We acknowledge receipt of your responses received via email dated September 11 and 21, 2017, which included documentation describing corrections to the observations of concern noted on the FDA-483. However, after evaluation of your revised HACCP plan for aseptic fruit purees and concentrates, which includes apple juice puree and puree concentrate, your responses are not adequate, as further described in this letter.

In accordance with 21 CFR 120.9, failure of a processor of juice products to have and implement a HACCP plan that complies with 21 CFR 120, or otherwise operate in accordance with the requirements of this part, renders the juice products adulterated within the meaning of section 402(a)(4) of the Food, Drug and Cosmetic Act (the Act), 21 U.S.C. § 342 (a)(4). Accordingly, your apple juice puree and puree concentrate products are adulterated in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health. You may find the Act, the juice HACCP regulation, and the Juice HACCP Hazards and Controls Guidance through links in FDA's home page at www.fda.gov.

Your significant deviation 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)(l). A "food hazard" is defined in 21 CFR 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 revised HACCP plan for aseptic fruit purees and concentrates, which includes apple juice puree and concentrates, does not list the food hazard of patulin. Patulin contamination of apples is a chemical hazard that is reasonably likely to occur and would necessitate a critical control point (CCP) for its control.

According to your September 21, 2017 response " ... patulin itself cannot be a CCP", and you have addressed patulin through other prerequisite programs. The prerequisite program identified in your hazard analysis is not an adequate substitute for control measures included in a HACCP plan because they do not meet the regulatory requirements of the juice HACCP regulation, 21 CFR 120. Consequently, your firm needs to identify patulin as a hazard in your HACCP plan and include adequate corresponding CCPs, critical limits, monitoring procedures, recordkeeping, etc., to control this hazard.

Additional information regarding the chemical hazard of patulin and controls measures to be incorporated into your juice HACCP plan can be found at: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm072557.htm.

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 this deviation. More specifically, your response should include documentation reflecting the changes you made, such as a copy of your revised HACCP plan or plans, five (5) consecutive days of completed monitoring records (i.e., records for the production of 5 production date codes of the products) to demonstrate implementation of the plan or plans, 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 applicable laws 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 violation

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 apple juice products under section 80l(a) of the Act (21U.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 juice HACCP regulation is Import Alert #20-07. You may view this alert at: http://www.accessdata.fda.gov/cms_ia/ialist.html

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 juice HACCP regulation, and the Good Manufacturing Practice regulation (21 CFR
110). You also have a responsibility to use procedures to prevent further violation(s) of the Act and all applicable regulations.

Additionally, Section 743 of the Act (21 U.S.C. § 379j-31) authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified
noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. § 379j-3 l(a)(2)(B)). For a foreign facility, FDA will assess and collect fees for re-inspection-related costs from the U.S. Agent for the foreign facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs. Please consider providing a copy of this letter to your U.S. Agent.

Please send your reply to Food and Drug Administration, Attention: Brandon Bridgman, Compliance Officer, Food Adulteration Assessment Branch (HFS-607), Division of Enforcement, Office of Compliance, 5001 Campus Drive, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Mr. Bridgman via email at brandon.bridgman@fda.hhs.gov. Please reference #538029 on any submissions and within the subject line of any emails to us.

William A. Correll
Office of Compliance
Center for Food Safety
  and Applied Nutrition

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