Inspections, Compliance, Enforcement, and Criminal Investigations
Pacific Rim Seafood 15-Apr-05
Department of Health and Human Services
Public Health Service
San Francisco District
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Our Reference: FEI 3003690373
April 15, 2005
Rodney Lyle Davis, Owner
Pacific Rim Seafood
32310 North Harbor Drive
Fort Bragg, California 95437
Dear Mr. Davis:
On January 19, 20, and 21, 2005, the United States Food and Drug Administration (FDA) inspected your seafood processing facility located at 32310 North Harbor Drive, Fort Bragg, California. We found that you have a serious deviation from the seafood Hazard Analysis and Critical Control Points (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). 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 this part, renders the fish and 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 refrigerated, ready-to-eat sea urchin roe is adulterated, in that it has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation, and the FDA's Fish & Fisheries Products Hazards & Controls Guidance, 3rd edition, June 2001 through links in FDA's home page at www.fda.gov. We listed the deviation on a Form FDA 483 and discussed them with you at the conclusion of the inspection.
Your serious deviation was:
You must conduct or have conducted for you, a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur, and you must have a written HACCP plan to control any food safety hazards that are likely to occur, to comply with 21 CFR 123.6(a) and (b). However, your firm does not have a HACCP plan for refrigerated, ready-to-eat sea urchin roe to control pathogen growth and toxin formation as a result of time/temperature abuse, a hazard which-is reasonably likely to occur in this product
This same, violation was brought to your attention following our previous inspection in June 2002, and remains uncorrected.
You must immediately take appropriate steps to correct the violation. We may take further action if you do not promptly correct the violation. For instance, we may take further action to seize your products and/or enjoin your firm from operating. Please respond in writing within fifteen (15) working days of receipt of this letter. Your response should outline the specific things you are doing to correct the violations. You may wish to include in your response documentation such as copies of your HACCP plan, HACCP monitoring 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 seafood HACCP regulations and the Current Good Manufacturing Practices (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Your response should be directed to: Ms. Erlinda N. Figueroa, Compliance Officer, U.S. Food and Drug Administration, 1431 Harbor Bay Parkway, Alameda, CA 94502-7070. If you have any questions regarding any issue in this letter, please contact Ms. Figueroa at (510) 337-6795.
Barbara J. Cassens
San Francisco District