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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Cargill Flavor Systems Puerto Rico Inc. 3/30/09


Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
  466 Fernandez Juncos Avenue
San Juan, Puerto Rico, 00901
Compliance Branch
Telephone: 787-474-9500
FAX: 787-729-6658


March 30, 2009



Certified Mail
Return Receipt Requested

Mr. Luis A. Santiago
Plant Manager and Site Superintendent
Cargill Flavor Systems PR Inc.
P.O.Box 145230
Arecibo, PR 00614-5230

Dear Mr. Santiago:

We inspected your juice processing facility, located at road number 652, KIn 1.0, Bo. Higuillales, Arecibo, PR 00612, on December 17-18,22-23,2008, and January 13,2009. We found that you have a serious violation of the juice Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 120 (21 CFR 120). In accordance with 21 CFR 120.14(d), if assurances do not exist that an imported juice has been processed under conditions that are equivalent to those required of domestic processors, the product will appear to be adulterated. Because our inspection identified a serious violation of 21 CFR Part 120, your frozen passion fruit juice and apple juice concentrates are adulterated Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)] in that they have been prepared, packed, or held under insanitary 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 violation was as follows:

You must either obtain the juice that you import from a country that has an active memorandum of understanding (MOU) or similar agreement with the FDA that covers the juice you import [21 CFR 120.14(a)(1)] or have and implement written procedures for ensuring that the juice you import was processed in accordance with FDA's Juice HACCP requirements [21 CFR 120.14(a)(2)]. These written procedures must include product specifications that are designed to ensure that the juice is not adulterated under section 402 of the Act because it may be injurious to health or because it may have been processed under insanitary conditions [21 CFR 120. 14(a)(2)(i)] and affirmative steps to ensure that the juice being offered for entry was processed under controls that meet the requirements of FDA's juice HACCP regulation [21 CFR 120.14(a)(2)(ii)].

Your firm receives juice concentrate from countries with which FDA does not have an applicable active MOU Therefore, your firm must have and implement the written procedures required under 21 CFR 120.14(a)(2). However, our investigator determined that your firm does not have such procedures for your imported juice products. For example, in April and May of 2008, your firm imported 100 drums of frozen passion fruit juice concentrate from Ecuador and 144 drums of apple juice concentrate from China, respectively, but failed to have and implement a written procedure that provided product specifications for these juice concentrates and affirmative steps to ensure that these juice concentrates had been processed in accordance with the juice HACCP regulations.

We may take further action if you do not promptly correct these violations. For instance, we may take further action to refuse admission of your imported juice under section 801 of the Act (21 U.S.C. 381(a)), including placing it on detention without physical examination, seizing your products, and/or enjoining your firm from operating.

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. You should include in your response documentation such as HACCP and verification records, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.

This letter may not list all the violations at your facility. You are responsible for ensuring that your firm operates in compliance with the Act and the juice HACCP regulation (21 CFR Part 120). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

Please send your reply to the Food and Drug Administration, Attention: Ms. Margarita Santiago,Compliance Officer, at 466 Fernandez Juncos Avenue, San Juan, Puerto Rico 00901-3223. If you have questions regarding any issue in this letter, please contact Ms. Santiago at 787-474-9538 or margarita.santiago@fda.hhs.gov.



Maridalia Torres
San Juan District Director