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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Truluck's Seafood LTD 04-Jun-07

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

Public Health Service
Food and Drug Administration

 

555 Winderley PI., Ste. 200
Maitland, Fl 32751


CERTIFIED MAIL
RETURN RECEIPT REQUESTED

WARNING LETTER

FLA-07-21

June 4, 2007

Patty N. Tuner, Owner
Truluck's Seafood LTD
Dba Capri Fisheries
3 Ourlane Cove
Houston, Texas 77024

Dear Ms. Tuner:

We inspected your seafood processing facility, Capri Fisheries located at 218 Kon Tiki Drive, Naples, Florida 34113-8661 on May 8& 10, 2007. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 & 110). In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery 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, species 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 seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.

You significant violations were as follows

• You must implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b). However, your firm did not record monitoring observations at the receiving and storage critical control points (CCP) to control histamine formation listed in your HACCP plan for scombroid species. For example:

o Your HACCP plan states at the receiving CCP that "All lots received are accompanied by harvest vessel records that show proper handling of the product" however from March 9, 2007 to April 16, 2007 your firm received scombroid species (i.e. King Mackerel) directly from fishing vessels eighteen times without accompanying harvest vessel records.

o Your HACCP plan states at the storage CCP that "Temperature And constant presence of ice" will be monitored however there are no monitoring records documenting this activity from March 9, 2007 to April 16, 2007 when your firm received and stored scombroid species (i.e. King Mackerel).

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.

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 seafood HACCP regulation (21 CFR Part 123) 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: Brant M. Schroeder, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida, 32751. If you have any questions regarding any issue in this letter, please contact Mr. Schroeder at (407) 475-4763.

Sincerely,

/S/

Emma R. Singleton
Director, Florida District