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  5. Pacific Hi - Tak Inc - 12/05/2014
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Pacific Hi - Tak Inc

Pacific Hi - Tak Inc

United States

Issuing Office:
San Francisco District Office

United States


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 


UNITED PARCEL SERVICE                                                         
December 5, 2014
Mr. Hideyoshi Takasawa, President
Pacific Hi-Tak Incorporated
1020 Auahi St., Suite 4160
Honolulu, Hawaii 96814
Dear Mr. Takasawa:
We inspected your seafood processing facility, located at 1020 Auahi Street, Suite 4160, Honolulu, Hawaii 96814 on August 12-21, 2014.  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 refrigerated, vacuum packaged and non-vacuum packaged fresh Yellowtail (Hamachi) fillets 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 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 “[f]resh Yellowtail fillet (Hamachi) vacuum packaged” lists monitoring procedures and frequencies at the “[r]efrigerated [s]torage” critical control point that are not adequate to control Clostridium botulinum toxin formation. Specifically, your HACCP plan does not list that you will conduct a visual check of the recorded data at least once daily to ensure that the critical limit of 38°F or below has been met.
Note: You currently have separate HACCP plans for each significant hazard for “[f]resh Yellowtail fillet (Hamachi) vacuum packaged,” and “[f]resh ocean caught Japan [f]ish” rather than including all the hazards reasonably likely to be associated with the product in its entirety. For example, you have separate plans identifying histamine formation, pathogenic bacteria growth and toxin formation as a result of time and temperature abuse, and Clostridium botulinum toxin formation in finished product for the fresh Yellowtail fillet (Hamachi) vacuum packaged. While we do not object to separate plans, including all critical control points in a single plan and adopting the most conservative controls when multiple hazards occur at a single critical control point (e.g. establishing a critical limit of 38°F at the finished product refrigerated storage to control Clostridium botulinum growth and toxin formation), and identifying all of the hazards in that one plan would simplify your HACCP plan, making it easier to assure that the necessary controls are in place and implemented.
  1. You must have a HACCP plan that 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 vacuum packaged fresh Yellowtail fillet (Hamachi) lists the critical limits of “[a]dequate quantity of frozen gel packs…,” and “[n]ear surface fish temperature maintained at 38F or below” at the “[r]eceiving” critical control point which are not adequate to control the hazards of Clostridium botulinum toxin formation, pathogenic bacteria growth and toxin formation, and histamine because these critical limits do not ensure that all the fish in each tote have been maintained at proper temperatures.
Specifically, FDA recommends critical limits that ensure that all of the vacuum packaged fish fillets are maintained under proper chilled conditions throughout transit to your facility. For example, by “[a]dequate quantity of frozen gel packs” FDA recommends that your firm also ensure you are monitoring the frozen condition of a representative number of gel packs that should be completely surrounding the fish. In addition, FDA recommends monitoring temperatures of packages of fish located within the centers of the containers rather than only those located near the surface of the shipping container.  
In addition your HACCP plans list critical limits at the “[r]efrigerated storage” critical control points in each plan as “[m]aintain cooler temperature at 38F or below”, “[f]rozen status of gel packs”, “[n]ear surface temperature maintained at 38F or below.” FDA considers the monitoring of the cooler temperature with equipment capable of continuously monitoring and recording the cooler temperatures the most appropriate critical limit to be implemented. The other listed limits will not provide a safety assurance equivalent to that control. 
  1. You must implement the monitoring procedures and record keeping system that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b). However, your firm did not follow the monitoring procedures at the “[r]eceiving” critical control point for any of your HACCP plans. Additionally, your firm did not record monitoring observations at the “[r]eceiving” critical control point to control any identified hazard listed in your HACCP plans for either “[f]resh Yellowtail fillet vacuum packaged” or “[f]resh ocean caught Japan [f]ish.” Specifically,
·    With regard to your failure to implement the monitoring procedures and frequencies in your plan:
i.   On August 12, 2014, your receiving employee did not monitor the “[q]uantity and frozen condition of gel packs” and “[f]ish temperature” for “[e]very fish received” for your “[f]resh Yellowtail fillet vacuum packaged.” Your employee only checked the condition of the gel packs on the top layer and the near surface temperature of the fish on the top layer, closest to the gel packs. This is not sufficient to ensure all the fish in the container are at or below 38°F.
ii.   On August 12, 2014, your receiving employee did not monitor the “internal temperatures of a representative number of product units” for “[e]very lot received,” as required by your “[f]resh ocean caught Japan [f]ish” HACCP Plan to control the hazards of “[h]istamine formation” or “[p]athogenic bacteria growth and toxin formation as a result of time and temperature abuse” at the “[r]eceiving” critical control point. The employee did not check the internal temperature of the fish, instead checked only the near surface temperature of the top layer of fish.
·    With regard to your firm’s failure to implement the recordkeeping system listed in your plan:
i.   Based on the records you provided during the inspection, you did not record the condition or quantity of gel packs or near surface temperatures of the “[f]resh Yellowtail fillet (Hamachi) vacuum packaged” or “[f]resh ocean caught Japan [f]ish” products you received on July 29, 2014 or August 1, 2014.
ii.  Based on the records you provided for a shipment you received on May 9, 2014, you recorded temperatures and condition of gel packs with handwritten notes, and did not use the “[r]eceiving record” listed in your HACCP plans. You also explained that the shipper provides the “[r]eceiving record,” titled FISH RECEIVING LOG, prefilled with the initials of (b)(4). Records should be contemporaneous and reflect the initials of the actual person who made the observation.
  1. You must take corrective actions when a deviation from a critical limit occurs, to comply with 21 CFR 123.7(a). However, your firm did not take corrective action to control the hazard of Clostridium botulinum growth and toxin formation in your vacuum packaged products when your data temperature logger documented temperatures above your critical limit of 38°F at the refrigerated storage critical control points in your HACCP plans. Your temperature data recording chart for June 16 – 23, 2014, shows temperatures of about 60-70°F for 6 of 7 days, and includes a notation “dropped machine” on the reverse. Our review of subsequent charts, through July 21, 2014, also document temperatures of about 60-70°F.   You did not repair or adjust the device to ensure the readings were accurate when a critical limit deviation was documented.
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.

Please note that per 21 CFR 123.10, your HACCP plan should be developed, reassessed and modified, and records reviewed by an individual who has successfully completed training in the application of HACCP principles. However, during our inspection we found that the (b)(4) employees responsible for these functions have not been adequately trained in seafood HACCP. You should see to it that at least one of the employees responsible for your seafood HACCP program is adequately trained.
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: 

Lawton W. Lum
Director of Compliance
1431 Harbor Bay Parkway
Alameda, California 94502
Refer to the Unique Identification Number CMS case #440184 when replying.
If you have any questions about the content of this letter please contact Ms. Aleta T. Flores, Compliance Officer at (510) 337-6821.
Kathleen M. Lewis, J.D.
District Director