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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Seaside Fish Company 20-Jun-03

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

Public Health Service
Food and Drug Administration

 

San Francisco District
1431 Harbor Day Parkway
Alameda, CA 94502-7070
Telephone: 510/337-6700



VIA FEDERAL EXPRESS

Our Reference: FEI/CFN 3000215662/2953342
Seaside Fish Company

June 20, 2003

Antonio and Juan M. Rodriguez, Owners
Seaside Fish Company
205 Yale Company
Princeton By The Sea, California

WARNING LETTER

Dear Mr. Antonio and Mr. Juan M. Rodriguez:

On May 8 and 9, 2003, we inspected your seafood processing facility,Seaside Fish Company, located at 2005 Yale Avenue, Princeton By The Sea, California.

We found that you have a serious deviation from the Seafood HACCP regulations in Title 21, Code of Federal Regulations, Part 123 (21 C.F.R. Part 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 operates in accordance with the requirements of this part, 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 refrigerated histamine forming fish, e.g., tuna, and Mahimahi are adulterated, in that the products have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act and the Seafood HACCP regulations through links in FDA's home page at www.fda.gov. See attached handout on how you can obtain a copy of the Fish & Fisheries Products Hazards & Controls Guidance, 3rd edition, June 2001. We listed the deviation on a Form FDA 483 and discussed them with Mr. Antonio Rodriguez at the conclusion of the inspection. We are enclosing a copy of the FDA 483 for your reference. Your serious HACCP deviation was:

You must conduct 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 reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b). However, your firm does not have a HACCP plan for refrigerated histamine forming fish such as Mahimahi and tuna, to control the food safety hazard of histamine formation as a result of time/temperature abuse.

You must inmediately take appropriate steps to correct the violation at your facility. We may initiate regulatory action without futher notice if you do not correct the problem. For instance, we may take futher action to seize your products 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 that you are doing to correct the deviation. You may wish to include in your response documentation such as copies of your HACCP plans, temperature 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 deviations.

This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the Seafood HACCP regulations and the Good Manufacturing Practice regulations (21 C.F.R. Part 110). You also have are 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 94502-7074: If you have any questions regarding any issue in this letter, please contact Ms. Figueroa at (510)337-6795.

Sincerely,

/S/

Dennis K. Linsley
District Director
San Francisco District

.