Inspections, Compliance, Enforcement, and Criminal Investigations
Trans-Caribbean Dairy Corporation
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
September 25, 2009
RETURN RECEIPT REQUESTED
Mr. Fred W. Hintz
Trans-Caribbean Dairy Corporation dba St. Thomas Dairies
P.O. Box 4800
St. Thomas, VI 00801
Dear Mr. Hintz:
We inspected your dairy, 1000./0 fruit juices, and fruit juice beverages processing facility, located at 71 St. Joseph & Rosendahl, St. Thomas USVI on June 30 and July 1, 2009. 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 have and implement a HACCP plan that complies with this section or otherwise 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 1000./0 pineapple, apple, grape, orange, and orange-pineapple juices 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). You must implement the record keeping system listed in your HACCP plan, to comply with 21 CFR 120.8(a). However, your firm did not record monitoring observations at the Pasteurization critical control point to control the pathogen hazard listed in your HACCP plan for 100% juices, such as pineapple, apple, grape, orange, and orange pineapple from concentrate. Specifically, your HACC plan states that you will record the flow rate of your pasteurizer. However, there are no records showing that you have ever performed this monitoring procedure.
2). You must monitor conditions and practices during processing with sufficient frequency to ensure conformance with current good manufacturing practice regulations, to comply with 21 CFR 120.6(b). However, your firm did not monitor the protection of food, food packaging material, and food contact surfaces from adulteration with sufficient frequency, as evidenced by the following observations:
• Pooled dirty water was observed on the lid of juice concentrate and juice bases in plastic containers stored in the juice and eggs cooler.
• Accumulation of dust, grease, and debris in the housing of the (b)(4) filling machine that holds the plastic roll used to form the pouch or plastic containers for juice.
• Accumulation of dust on the surface of a plastic sleeve type ventilation channel suspended over processing equipment in the production room.
• Ice accumulation, water leaks, and condensation drippings in the storage freezers and coolers.
We may take further action 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 in violation of Section 402(a)(4) of the Act (21 U.S.C. § 342(a)(4) and the juice HACCP regulation.
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 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: Carlos A. Medina, Compliance Officer, 466 Fernandez Juncos Avenue, San Juan, Puerto Rico, 00901-3226. If you have questions regarding any issues in this letter, please contact Mr. Medina at 787-474-4789 or at firstname.lastname@example.org.
San Juan District
Enclosure: FDA 483