Inspections, Compliance, Enforcement, and Criminal Investigations
Deep Blue Seafood 03-Oct-07
Department of Health and Human Services
Public Health Service
Denver District Office
October 3, 2007
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Mr. Derrick R. Kinsey
Deep Blue Seafood
1846 Prospector Avenue
Park City, UT 84060
Ref. #: DEN-08-01SW2
Dear Mr. Kinsey:
An investigator from the U.S. Food and Drug Administration conducted an inspection of your seafood processing facility located at 1846 Prospector Avenue, Park City, Utah, on September 13-14, 2007. Our investigator found that you have serious violations from the seafood Hazard Analysis and Critical Control Points (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123) and the Current Good Manufacturing Practice regulation for foods, 21 CFR 110. In accordance with 21 CFR 123.6(g), failure of a processor 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 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, your firm's seafood products, such as, fresh fish and pasteurized crabmeat 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 FDA Fish and Fisheries Products Hazards and Controls Guidance through links on FDA's homepage at http://www.fda.gov.
The significant violations observed were as follows:
1. You must have a HACCP plan that, at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6(c)(3). A critical limit is defined in 21 CFR 123.3(c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard."However, your firm's HACCP plan for scombroid species of fish and canned pasteurized blue crab meat does not list the critical limits at the receiving and storage critical control points to control the hazards of histamine formation and Clostridium botulinum, respectively.
2. You must have a HACCP plan that, at a minimum, lists monitoring procedures for each critical control point, to comply with 21 CFR 123 .6(c)(4). However, your firm's HACCP plan for scombroid species of finfish and canned pasteurized blue crab meat does not list the monitoring procedures and frequency at the receiving and storage critical control points, to control the hazards of histamine formation and Clostridium botulinum, respectively.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your products and/or enjoin your firm from operating.
During the inspection, you informed our investigator that you would be attending a seafood HACCP training course in November. We encourage you to take the form FDA-483 which was .issued to you at the close of the inspection, and this Warning Letter with you to the course, to assist you and your instructors in preparing an adequate HACCP plan for your firm.
You should respond in writing within 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 verifications 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 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, P.O. Box 25087, Denver, CO 80225, Attention: William H. Sherer, Compliance Officer. If you have any questions regarding any issues in this letter, please contact Mr. Sherer at (303) 236-3051.
B. Belinda Collins
Denver District Director