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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Organizaciion Agricultores Bo. Espino 08-Oct-08

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

Public Health Service
Food and Drug Administration


San Juan District Office
466 Fernandez Juncos Avenue
San Juan, Puerto Rico, 00901
Telephone: 787-474-9510
FAX: 787-729-6658

October 8, 2008




Mr. Anastasio Silva
Organizacion Agricultores Bo. Espino
HC-30 Box 32213
San Lorenzo, PR 00754-9721

Dear Mr. Silva:

We inspected your fruit beverages and fruit pulp processing facility, located at Road 181 Km 12.5 San Lorenzo, PR on June 27, 2008, June 30, 2008, and July 3, 2008. We found that you have serious deviations from the juice Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 120 (21 CFR Part 120). In accordance with 21 CFR 120.9, failure of a processor of juice products 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 tamarind, passion fruit, and caribbean cherry (acerola) fruit pulps ("juices" within the meaning of 21 CFR § 120.1(a)) used to produce fruit beverages are adulterated, 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 HACCP regulation and the juice HACCP guidance documents through links in FDA's home page at http://www.fda.gov/.

Your significant violations were as follows:

1) At the time of our inspection, you did not pasteurize your fruit pulps, but instead relied on pasteurization of your fruit beverage products (which contain the pulps) as a critical control point (CCP) for control of microbiological hazards that are reasonably likely to occur during the processing of your pulps. You must maintain records documenting the monitoring of critical control points and their critical limits, including the recording of actual times, temperatures, or other measurements to comply with 21 CFR 120.12 (a)(4)(i).

However, you do not have records to show that you pasteurized your tamarind, caribbean cherry, and passion fruit beverages containing your pulps during the period of February 2008 through April 2008. In addition to this complete gap in your records for the dates above, our inspection determined that your tamarind beverage pasteurization records are deficient as set forth below.

  • Your records for 11/28/07, 12/3/07, 12/24/07, 1/3/08, 1/16/08, and 1/23/08 are blank or illegible.

  • Your records for 4/2/08 and 5/15/08 do not include the temperature/time gradients.

These are very serious deficiencies because you are relying on the pasteurization step of your beverage manufacturing process to control microbiological hazards that are reasonably likely to occur during the processing of your fruit pulps.

2) You must have sanitation control records that document monitoring and corrections to comply with 21 CFR 120.6(c) and 120.12(a)(1). However, your firm did not maintain sanitation control records of the condition and cleanliness of food contact surfaces, including utensils, gloves, and outer garments. Specifically, your most recent record that documents the monitoring of cleaning and sanitizing activities for all your processing equipment is dated February 15, 2008, even though after this date you have been processing pulp and manufacturing beverages two or three times a week.

We note that during the inspection, your firm produced an updated HACCP plan. Your firm's Plant Manager, Ms. Ledya Silva, indicated that you would correct all identified deficiencies and implement the new HACCP plan within three weeks after the inspection.

We may take action without further notice if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.

Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you have done and 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, we expect that you will 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 processing plant operates in compliance with the Act, the juice HACCP regulation (21 CFR Part 120) and the Current Good Manufacturing Practice regulation (21 CFR Part 110). 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: Margarita Santiago, Compliance Officer, 466 Fernandez Juncos Avenue, San Juan, Puerto Rico, 00901-3226. If you have questions regarding any issues in this letter, please contact Ms. Santiago at 787-474-4789.



Mandalia Torres
District Director
San Juan District

Enclosure: FDA 483

cc: Mrs. Ledya Silva, Plant Manager