| Public Health Service Food and Drug Administration |
| Los Angeles District Pacific Region 19701 Fairchild Irvine, CA 92612-2506 Telephone: 949-608-2900 FAX: 949-608-4415 |
Department of Health and Human ServicesWARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
June 14, 2010
W/L 26-10
Mr. David J. Rudie, President
Catalina Offshore Products
5202 Lovelock St
San Diego, CA 92110
Dear Mr. Rudie:
We inspected your seafood processing facility, located at 5202 Lovelock St, San Diego, CA 92110 on April 05-09, 2010. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 and the Current Good Manufacturing Practice (cGMP) regulation for foods, Title 21, Code of Federal Regulations, Part 110. In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HAACP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) ofthe Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 342(a)(4). Accordingly, your ready-to-eat raw sea urchin and tuna loin 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 HAACP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
We acknowledge the receipt of your written response letter dated April 19, 2010. The agency has reviewed your response and although some of the items that were discussed during the close out of the inspection appear to have been corrected (Observation 15, posting of signs near the hand washing station), we continue to have the following concerns. We address your response below, in relation to each ofthe noted violations.
Your significant violations were as follows:
1. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR 123.11(b), However, your firm did not monitor (1) the safety of the water that comes into contact with food or food contact surfaces, or is used in the manufacture of ice; (2) condition and cleanliness of food contact surfaces, including utensils, gloves, and outer garments; (3) 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; (4) maintenance of hand washing hand sanitizing, and toilet facilities; with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by:
a. hoses lacking backflow devices
b. chemical proportion and metering equipment used for detergent and sanitizing solutions were connected to the internal water system without backflow device
c. seafood residue observed on food contact surfaces, equipment and clothing
d. employees touching insanitary surfaces and then handling food
e. frozen condensate dripping onto frozen seafood
f. lack of screens or filters in turbines over processed sea urchin
g. floor cleaning overspray contacting equipment, raw materials and fish
h. lack of soap and paper towels at production room sink
i. leaking toilet waste water in the men's restroom
Your response does not adequately address this violation. We acknowledge that you state to have begun to improve employee training. Also, that you: will make sure all hoses have backflow devices; changed the basket cleaning procedure; will replace the cutting boards; repair the employee hand wash station; repair restroom; improve the cleaning of food contact surfaces; and review cleaning records. However, you did not provide evidence of training, record review, procedure revision, record of equipment purchase, or documentation of completed repairs.
2. You must maintain adequate sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR 123.11(b), to comply with 21 CFR 123.11(c). However, your firm did not maintain sanitation monitoring records for maintenance of hand washing, hand sanitizing, and toilet facilities required for the processing of ready-to-eat sea urchin from 04/05-07/10. The records are inadequate because the requirements of 21 CFR 123.9(a)(2) [the date and time of the activity that the record reflects] and 123.9(a) (3) [the signature or initials of the person performing the operation] from 04/05-07/10 are not present.
Your response does not adequately address this violation. We acknowledge that you have started to improve your reviews and sanitation record monitoring including cross contamination and operation of the employee hand washing station. However, you did not provide evidence of the reviews, monitoring, and operation of the hand washing station.
3. You must implement the monitoring procedures and frequency that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4). However, your firm did not follow the monitoring procedure (b)(4) at the storage critical control point to control histamine as listed in your HACCP plan for tuna loin.
Your response does not adequately address this violation. We acknowledge that you stated in the response that you will improve your monitoring and review of scombroid species to make sure loins and fillets are wrapped and held on ice as well as review of employee practices. However, you did not provide evidence of the review of employee practices or records of the checks for ice on fish.
4. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce 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 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 (b)(4) does not list the food safety hazards of environmental chemicals and pesticides.
5. 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 (b)(4) lists a critical limit (b)(4) °F at "Storage" critical control point that is not adequate to control pathogen growth. FDA recommends a storage temperature of 40°F or below to control pathogen growth.
6. 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, as primary processor your firm's HACCP plan for (b)(4) does not list critical limits associated with sensory evaluation as indicators of decomposition at the (b)(4) critical control point. FDA recommends that primary processors conduct sensory examination on representative samples of fish (i.e., at least 118 fish in a lot) to demonstrate no more than 2.5% decomposition. For example, no more than 3 fish in a sample of 118 fish may show signs of decomposition.
7. 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 CFR 123.6(a) and (c)(2). A critical control point is defined in 21 CFR 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 (b)(4) does not list the critical control points of "processing and packaging" for controlling the food safety hazards of pathogen growth and histamine.
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. You should respond in writing within fifteen (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 verification 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 Part 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, Attention:
Blake Bevill
Director, Compliance Branch
Los Angeles District
19701 Fairchild
Irvine, CA 92612-2506
If you have questions regarding any issues in this letter, please contact Dr. Raymond W. Brullo, Compliance Officer at 949-608-2918.
Sincerely,
/s/
Alonza E. Cruse
District Director
Los Angeles District
Cc: Branch Chief
Food and Drug Branch
California Department of Public Health
1500 Capitol Avenue-MS 7602
P.O. Box 997413
Sacramento, CA 95899-7413
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