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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Sovereign Seafoods, Inc. 01-Feb-05

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

Public Health Service
Food and Drug Administration


Food and Drug Administration
Los Angeles District
19701 Fairchild
Irvine, CA 92612-2506
Telephone (949) 608-2900



W/L 08-05

February 1, 2005

Alfred Ballabio, President
Sovereign Seafoods, Inc .
215 Helena Ave.
Santa Barbara, CA 93101

Dear Mr. Ballabio:

On September 16-22, 2004 we inspected your seafood processing facility, located at 215 Helena Ave., Santa Barbara, California. We found that you have serious deviations 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 fishery products processed there 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 fish fillets are adulterated, in that the fillets have been prepared, packed, or held under insanitary conditions whereby they have been contaminated with filth, or have been rendered injurious to health. You may find the Act and the Seafood HACCP Regulation through links in FDA's home page at www.fda.gov.

The deviations were as follows:

1. 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 cooler temperature critical control point to control for pathogens and histamine toxins as listed in your HACCP plan.

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 lists a monitoring frequency at the chilled storage critical control point that is not adequate to control for pathogens and histamine. Specifically your HACCP plan states that the cooler temperature is monitored "frequently" and the cooler temperature recorded once daily. The word "frequently" is not specifically definable. One option, acceptable to FDA, is to use continuous temperature monitoring equipment for checking the chilled storage area, with a visual check of the instrument at least once per day.

3. Since you chose to include corrective actions in your HACCP plan, your described corrective actions must comply with 21 CFR 123.7(b). However, your corrective action plan for exceeding "40 degrees" at the Chilled Storage critical control point to control for pathogens, histamine, and decomposition does not identify procedures to evaluate the product for time/temperature abuse to determine the safety of the product.

4. You must adequately monitor sanitation conditions and practices during processing to comply with 21 CFR 123.11(b). However, your firm did not monitor:

  • the condition and cleanliness of food or food contact surfaces, including utensils, gloves, and outer garments with sufficient frequency to ensure conformance with 21 CFR 123 .11(b)(2), as evidenced by coffee mugs, cups, and dried crusted debris having been observed on the saw used to cut frozen fish.

  • the prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces, including utensils, gloves, and outer garments, and from raw product to cooked product to ensure conformance with 21 CFR 123.11(b)(3), as evidenced by:

  • 1. personal food and beverages having been observed inside the ice machine;

    2. a water bottle, coffee maker, and a microwave oven having been observed in the fish products processing area; and

    3. personal food and beverages having been observed on the top shelf above fresh fish products in the cold storage area.

  • the maintenance of hand washing, hand sanitizing, and toilet facilities to ensure conformance with 21 CFR 123.11(b)(4), as evidenced by the fact that there was no running hot water in the fish processing area.

  • the protection of food from adulteration with condensate as well as from other chemical, physical and biological contaminants to ensure conformance with 21 CFR 123.11(b)(5), as evidenced by:

  • 1.condensation having been observed dripping on unprotected fish in the cold storage area, and

    2. uncovered and unprotected fresh fillet fish having been observed in the cold storage area.

5. You must maintain sanitation control records that, at a minimum, document monitoring and corrections to comply with 21 CFR 123.11(c): However, your firm did not maintain sanitation control records for monitoring any of the sanitation areas required by regulation including condition and cleanliness of food contact surfaces required for the processing fish labeled as "Sashimi" and meant for raw consumption.

In reviewing your HACCP plan, we noted that on Page 4 of 18, under the heading SPECIES, you state that this plan "INCLUDES BUT IS NOT LIMITED TO COD, SOLE, HALIBUT, . . .". The seafood HACCP regulation, at 21 CFR 123.6(a), requires a HACCP plan for each kind of fish and fishery product that you handle. Thus, your one plan cannot cover all possible products. The methods to control hazards for each product depend a number of factors, including the seafood species utilized, the hazards associated with that particular species, the preparation methods employed, and the final packed product, e.g. a vacuum packaged product versus a terminally cooked product. Similar products with similar hazards can, however, be grouped under a single HACCP plan. 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.

Please 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 deviations. You should include in your response documentation such as 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 regulation and the 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: John Stamp, Compliance Officer, 19701 Fairchild, Irvine, CA 92612. If you have questions regarding any issue in this letter, please contact Mr. Stamp at 949/608-4464.



Albnza E. Cruse