Inspections, Compliance, Enforcement, and Criminal Investigations
State Fish Company, Inc. Plant 1 31-Jan-03
Department of Health and Human Services
Public Health Service
19900 MacArthur Blvd., Ste 300
RETURN RECEIPT REQUESTED
January 31, 2003
Benito Caserma, PlantManager
State Fish Company, Inc. Plant 1
1130 West C Street
Wilmington, CA 90744
Dear Mr. Caserma:
On October 31 and November 4-5, 2002, we inspected your seafood processing facility identified as State Fish Company Plant l, located at 1130 West C Street, Wilmington, California. We found that you have serious deviations from the seafood HACCP Regulations, 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 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 vacuum-packaged raw fish, such as salmon and your IQF frozen shrimp, are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. You may find the Act and the Seafood HACCP Regulations through links in FDA's homepage at www.fda.gov.
The deviations were as follows:
1. You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6 (a) and (c) (1). A food safety hazard is defined in 21 CFR Part 123.3 (f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption."
However, your firm's HACCP plan for "Fish Whole Frozen, Precooked Frozen, Precooked and Processed" does not list the food safety hazard of undeclared sulfite inclusion for the Cooked IQF Shrimp repacked by your firm. You must ensure that existing sulfite inclusion is declared on the new labeling, replacing the original labeling.
2. You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points, to comply with 21 CFR123.6(a) and (c)(2). A critical control point is defined in 21 CFR Part 123.3(b) as a "point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels."
However your firm's HACCP plan for "Fish Whole Frozen, Precooked Frozen, Precooked and Processed" does not list a critical control point for Packaging to control the food safety hazard of Clostridium botulinum growth/toxin formation in your frozen, vacuum-packaged salmon steaks. Since your. firm has chosen to not label your frozen vacuum packed fish with handling instructions (e.g., Keep Frozen, Thaw under Refrigeration, Open Immediately), you must provide safety measures to control the hazard of Clostridium botulinum growth/toxin formation throughout shipping and handling. FDA currently recommends affixing time-temperature integrators to each individual package and ensuring that the integrators are present on each package at time of pack.
3. 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 Fish, Fresh Whole (Scombroid) does not list critical limits at Receiving to control the hazard of histamine. Your records indicate that you are a secondary processor of scombroid fish. As a secondary processor, FDA expects you to ensure that your fish have been safely handled during transport to your firm. FDA recommends that this be done by either monitoring a representative sample of internal temperatures for each lot of fish if shipment times are less than 4 hours or, if transport times are longer, by assuring that the fish are adequately cooled throughout shipment, such as monitoring the adequacy of the ice upon receipt. The periodic histamine checks your firm performs at Receiving are not a recommended control for a secondary processor. Chapter 7 of the Fish and Fisheries Products Hazards and Controls Guidance provides information regarding what limits and controls FDA considers adequate.
4. 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 Fish, Fresh Whole (Scombroid) lists a monitoring procedure (periodic temperature checks) at the Cooler critical control point that is not adequate to control histamine formation. You must assure that your scombroid fish are held at consistently safe temperatures. FDA does not consider periodic temperature checks an adequate method of showing that fish have not been exposed to abusive temperatures for periods of time. FDA recommends that temperatures be monitored continuously by either visually checking that adequate ice is covering the fish (twice daily) or by installing continuous temperature recording devices.
5. You must adequately monitor sanitation conditions and practices during processing, to comply with 21 CFR 123.11(b). However, your firm did not monitor prevention of cross-contamination from insanitary objects to food as evidenced by employees storing boxes that had come in direct contact with the floor over unprotected ready-to-eat IQF shrimp. Dirt and debris adhering to the bottom of the containers could drop onto the shrimp during the packing operation.
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. In addition, we may not provide certificates to your firm for export of your products to European Union (EU) countries if you do not correct these deviations.
Please notify this office in writing, within fifteen (15) working days of receipt of this letter, of specific steps you have taken to correct the noted violation and to prevent its recurrence. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. You may wish to include in your response documentation such as HACCP plans, corrective action forms, monitoring forms and recent monitoring data or other useful information that would assist us in evaluating your corrections.
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 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations.
If you have any questions relating to this letter you should contact Robert B. McNab, Compliance Officer, at (949) 798-7709. Your written reply should be addressed to:
Director, Compliance Branch
U.S. Food and Drug Administration
19900 MacArthur Boulevard, Suite 300
Irvine, California 92612-2445
Alonza E. Cruse, Director
Los Angeles District
cc: John DeLuca, President
State Fish Company, Inc.
2194 Signal Place
San Pedro, CA 90831