| Public Health Service Food and Drug Administration |
| San Francisco District 1431 Harbor Bay Parkway Alameda, CA 94502-7070 Telephone:510/337-6700 |
Department of Health and Human ServicesVIA UNITED PARCEL SERVICE
Our Reference: FEI 2920655
April 29, 2010
Dexter N. Okada, President
U. Okada & Company, Ltd.
1000 Queen Street
Honolulu, Hawaii 96814
WARNING LETTER
Dear Okada:
We inspected your seafood processing facility, U. Okada & Company Ltd., located at 1000 Queen Street, Honolulu, Hawaii, on January 22,25,26,27, and 29, 2010. We found that you have serious violations of the seafood Hazard Analysis and Critical of Federal Regulations, Part 123, and the Current Good Manufacturing Practice regulation for foods, Title 21 Code of Federal Regulations, Part 110 (21 CFR Parts 123 & 110). In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP 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) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4). Accordingly, your histamine forming fish (yellowfin, bonito, albacore, and mahimahi) 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 HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
Your significant violations were as follows:
1) 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 CFR 123.6(c)(4). However, your firm's HACCP plan for "AHI - YELLOWFIN, BIGEYE, ALBACORE, MARLIN - BLUE, STRIPED, WAHOO (ONO), MARI" lists a monitoring procedure (b)(4) at the Storage critical control point (CCP) that is not adequate to control histamine formation. For products that are stored under refrigerated conditions, we recommend a method of continuous monitoring and
recording storage temperature, i.e., a digital time/temperature data logger or a recorder thermometer, with visual check of the instrument at least once per day.
2) Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plan for "AHI - YELLOWFIN, BIGEYE, ALBACORE, MARLIN - BLUE, STRIPED, WAHOO (ONO), MAHI" at the Receiving CCP to control histamine formation is not appropriate and your corrective action plan at the Storage CCP is not adequate. The corrective action plan listed at the Receiving CCP (b)(4) cannot be accomplished based on your monitoring procedures. There is no means for you to determine the cumulative time that the product temperature (b)(4). Appropriate corrective actions may include rejecting any lot of fish that is received with (b)(4);or alternatively performing histamine testing on a representative number of fish in the lot and rejecting the lot if the histamine levels are greater than or equal to 50 parts per million.
At the Storage CCP, your corrective action plan does not have provisions to ensure that no product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation. For example, you may wish to perform histamine analysis, evaluate the product for time-temperature exposure, destroy the product, or divert it to a non-food use.
3) You must adequately 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 key sanitation areas with sufficient frequency to ensure control of:
a) Prevention of cross-contamination from insanitary objects to food - On January 22, 2010, our investigator observed that the plastic barrier between the refrigerator and the docking area/warehouse was filthy. Your employee was seen several times transporting, in a forklift, pallets of fresh, raw tuna fish through this passage, where the plastic barrier came in direct contact with the fish. Much of the tuna is sashimi grade and intended for raw consumption.
b) Protection of food, food packaging material, and food contact surfaces from adulteration - On January 22, 2010, our investigator observed that a shipment of tuna fish was directly on the floor of your refrigerated truck when it arrived.
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 U.S. Food and Drug Administration, Attention: Ms, Erlinda N. Figueroa, Compliance Officer, 1431 Harbor Bay Parkway, Alameda, CA 94502-7070. If you have questions regarding any issue in this letter, please contact Ms. Figueroa at (510) 337-6795.
Sincerely,
/s/
Darlene B. Almogela
Acting District Director
San Francisco District
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