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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Pacific Hi-Tak, Inc. 17-Mar-06

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

Public Health Service
Food and Drug Administration


San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
Telephone: 510/337-6700


Our Reference: FEI 1000522877

March 17, 2006

Hideyoshi Takasawa, President
Pacific Hi-Tak, Inc.
814 Ilaniwai Street
Honolulu, HI 96813-5223


Dear Mr. Takasawa:

We inspected your seafood processing facility, located at 814 Ilaniwai Street, Honolulu, Hawaii, on November 9, 10, 11, 14, 15, 16, and 17, 2005. 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 (21 CFR 123). 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 and your raw vacuum packaged finfish 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 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, to comply with 21 CFR 123.6(a). 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." On November 8, 2005, you received refrigerated, vacuum packaged, raw yellowtail fillets from [redacted] which you accepted without time/temperature integrators (TTIS) and which were subsequently distributed in the original packaging with the vacuum seals still intact. FDA considers refrigerated fresh fish products in vacuum packaging or modified atmosphere packaging to be adulterated under section 402(a)(4) of the Food, Drug, and Cosmetic Act when the Clostridium botulinum toxin is not controlled. FDA is aware of two ways to pack this product safely. First, a second barrier can be utilized. Second, an indicator can be used in/on individual packages to show that they have not been exposed to a time and temperature combination that could result in an unsafe product between the time of packaging and the time of use by the consumer. If you have conducted a hazard analysis, you would have concluded that there was a hazard that was not controlled. Please refer to http://www.fda.gov/ora/fiars/ora_import_ia16125.html for additional information regarding FDA's import criteria for vacuum packaged raw seafood. We note that your supplier, [redacted] is exempt from import detention contingent upon the use of Warm Mark 5C 41F TTIs. We also note that you agreed to ask your supplier to use TTIs per their agreement with FDA, for vacuum packaged products that the firm distributes. We encourage you to follow through on your commitment, if you have not already done so.

2) 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"FRESH [redacted]VWFISH: WHOLE (HISTAMINE FORMING SPECIES INCLUDING AJI (HORSE MACKERAL), IWASHI (SARDINE), SHIMAJI (JACK), KANPACHI (AMBERJACK), KOHADA (SHAD), HAMACHI (YELLOWTAIL), ETC" lists a monitoring frequency "VISUAL CHECK AT THE START, MIDDLE, AND AT THE END OF THE DAY" at the Cold Storage CCP that is not adequate to control histamine formation as a result of time/temperature abuse. FDA recommend's continuous monitoring of the cooler temperature or if ice is used as a coolant, monitoring of the adequacy of ice at appropriate frequencies. For non-vacuum packaged scombroid fish, cooler temperature may be maintained at 40°F maximum.

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 frequency of"CONTINUOUS MONITORING WITH VISUAL CHECK OF REFRIGERATOR TEMPERATURE AND ICE OR OTHER COOLING MEDIA. CHECK 3 TIMES A DAY, AND IMMEDIATELY PRIOR TO SHIPMENT" at the Refrigerated Storage CCP to control C. botulinum toxin formation and histamine formation listed in your HACCP plan for"FRESH YELLOWTAIL FILLET (HAMACHI) VACUUM PACKAGED." During the inspection, Mr. Kevin H. Hadano, Vice President, told the FDA investigator that your firm's refrigerated storage unit is not equipped with a continuous recorder thermometer nor outfitted with an alarm system.

4) 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:

a) "FRESHI [REDACTED] FISH: WHOLE (HISTAMINE FORMING SPECIES INCLUDING AJI (HORSE MACKERAL), IWASHI (SARDINE), SHIMAJI (JACK), KANPACHI (AMBERJACK), KOHADA (SHAD), HAMACHI (YELLOWTAIL), ETC" at the Cold Storage CCP, to control histamine, formation, is not adequate. Your HACCP plans lists: CONDUCT SENSORY ANALYSIS AFTER FISH IS PROPERLY CHILLED TO 40°F. REJECT/DESTROY IF EXCESSIVELY DECOMPOSED OR CANNOT DETERMINE TIME OVER 40°F. While rejecting decomposed fish is appropriate, it is not adequate to ensure that the remaining portions of the affected lot that meet sensory criteria are safe for distribution into commerce. If a lot exceeds the temperature criteria in your HACCP plan, FDA recommends that you perform histamine. analysis to determine safety and acceptability of the affected lot. Refer to FDA's Fish & Fisheries Products Hazards & Controls Guidance: Third Edition, page 97, for further explanation;

b) "FRESH YELLOWTAIL FILLET (HAMACHI) VACUUM PACKAGED" at the Refrigerated Storage CCP, to control. C. botulinum toxin formation and histamine .formation, is inadequate because there are no provisions to determine safety of the affected product in instances where you are able to verify the length of time the refrigerator temperature was over 38°F.

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) or enjoin your firm from operating.

You should respond in writing within fifteen (15) working days of 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 Federal Food, Drug, and Cosmetic 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 any questions regarding any issue in this letter, please contact Ms. Figueroa at (510) 337-6795.



Barbara J. Cassens
District Director
San Francisco District