| 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 Services
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
W/L 24-10
May 28, 2010
David E. Arpia, President/Owner
American Sea Food Company, Inc.
4904 North Harbor Drive #201
San Diego, CA 92106
Dear Mr. Arpia:
On February 1st - 18th, 2010 we inspected your seafood processing facility, located in 4904 North Harbor Drive #201, San Diego, CA 92106. 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 scombroid-forming fishes are adulterated, in that these fishes have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby it 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.
We acknowledge your written responses to the February 2010 FDA inspection. Two written responses were received by Los Angeles District Office; one on April 7th 2010 and the second on April 13th 2010. We have reviewed your responses, which included an updated HACCP plan. However, based on your response, your scombroid-forming fish continue to be adulterated. The deviations are as follows:
1. You must have a HACCP plan that at a minimum, lists 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 undated HACCP plan for "Fresh and Frozen Tuna," received on April 13, 2010, does not list adequate critical limits at the Receiving critical control point (CCP) to ensure that scombroid species received directly from the harvest vessel have been handled properly in order to control histamine formation. We note that your firm is occasionally the primary processor of tuna that is received directly from fishing vessels.
Your current critical limit, i.e. "All lots received are accompanied by harvest vessel records" is insufficient for controlling the hazard of scombrotoxin formation. In addition to collecting harvest vessel records for each, you should also conduct a sensory examination of at least 118 fish per lot and use a thermometer to the measure the internal temperature of a representative number of fish at receipt (minimum of 12 fish). Alternatively, if you receive scombroid species fish from vendors, other than harvest vessels, you must ensure that the fish is delivered with transportation records that show the fish was held at or below 40° F throughout transit or held under an adequate quantity of ice or chemical cooling media at the time of delivery. Please refer to the Fish and Fishery Products Hazard and Controls Guidance, chapter 7 - "Histamine Control" for more information on primary and secondary processor monitoring requirements.
In addition, we note that your firm processes other scombroid species fish, in addition to tuna, such as Mahi-Mahi. Your HACCP plan should reflect all your scombroid fish species.
2. You must implement the monitoring procedures and frequency that you have listed in your HACCP plan, to comply with 21 CPR 123.6(b) and (c)(4). However, your film did not follow the monitoring procedure of 1) internal temperature taken for each receipt of scombroid fish transported for 4 hours or less, and 2) checking the suppliers certification that they are following their HACCP plan at the Receiving critical control point to control histamine formation listed in your HACCP plan for "Fresh and Frozen Tuna," received on April 13, 2010. For example, your firm did not document product temperature or certificate information upon receipt for Tuna, Mahi-Mahi, and other histamine species on its receiving records for the months of Oct. 2009 to January 2010 as per the HACCP plan.
In addition, on 2/1/2010 at approximately 8:00 am, you received Tuna, Albacore, and Mahi-Mahi without checking the temperature or the adequacy of ice on receipt. This product was seen strapped closed in the cooler, on the a.m. of 2/2/10 and management stated that it still had not been monitored for its receipt. In addition, you did not assess the suppliers certificate that the product was handled correctly as per their HACCP plan as stated in your critical limits at Receiving.
3. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CPR 123.6(c)(4). However, your film's HACCP plan for "Fresh and Frozen Tuna," received on April 13, 2010, lists a monitoring procedure at the "Storage of fresh tuna in the plant" critical control point that is not adequate to control scombrotoxin formation. Specifically, your HACCP plan states that you will monitor the "icing of fish and/or storage in cooler." Your monitoring procedure, as written, allows you to alternate between checking that the fish is stored in the cooler and/or stored on ice. When scombrotoxin fish are stored in the cooler you will need to ensure that the fish is continuously held at the temperature specified in your critical limit and have equipment capable of providing a continuous record of the time/temperatures on a 24 hour a day/7 day a week basis.
4. You must maintain sanitation control records in accordance with 21 CPR 123.11(c) per the recordkeeping requirements detailed in 21 CFR 123.9(a). However, we observed that on 2/01/10, your firm did not accurately record your sanitation records with the actual date and time that the data was obtained. For example, the aforementioned record had data marked for the "6 AM" and "10 AM" checklist columns; however, it was determined that you were not able to record the "10 AM" data due to the fact that you were with the CSOs in another capacity at the time. At 11:00A, when the daily sanitation monitoring record was reviewed, it was determined that the data had been prefilled. Your sanitation records should reflect the accurate conditions in the plant, and must be recorded at the date and time when the activity actually took place. [FDA-483 item #9]
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 film for export of your products to European Union (EU) countries if you do not correct these deviations.
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 may wish to include in your response documentation such as revised HACCP planes), HACCP and sanitation 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 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.
Your written reply should be addressed to:
Blake Bevill
Director, Compliance Branch
Food and Drug Administration
19701 Fairchild
Irvine, CA 92612-2506
If you have any questions regarding this letter, please contact Mr. Robert B. McNab, Compliance Officer at 949-608-4409.
Sincerely,
/S/
District Director
Cc: California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue, MS-7602
P.O. Box 9974 13
Sacramento, CA 95899-7413
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