DEPARTMENT OF HEALTH & HUMAN SERVICES
February 17, 2012
Mr. Arvind Kant Patel
Tripacific Marine Limited
GPO Box 15184
Dear Mr. Patel:
We inspected your seafood processing facility, Tripacific Marine Limited located at Lot #16, Wailada Industrial Estate, Lami, Fiji on August 18-19, 2011, Upon further review of our investigator’s inspection report and findings during the inspection, we determined that you have serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) Regulation, Title 21, Code of Federal Regulations, Part 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 firm’s scombrotoxin (histamine) forming species of fish appear to be adulterated, in that the products have been prepared, packed, or held under whereby they may have been rendered injurious to health. At the conclusion of the inspection, the FDA investigator issued a FDA-483, Inspectional Observations, listing the deviations found at your firm.
We acknowledge receipt of your response dated August 22, 2011. This response to the FDA 483 that was issued to your firm at the conclusion of the inspection included a revised HACCP plan as well as completed daily sanitation records, harvest vessel records, organoleptic evaluation form, and fresh fish processing/packing checklist. However our review of the documentation revealed that the response was not adequate, as further described in this letter.
You may find the Act and the Seafood HACCP regulation through links in FDA’s home page at www.fda.gov.
We note the following serious deviations from the requirements of the Seafood HACCP regulation:
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 revised HACCP plan provided in your August 22nd response entitled, “Fresh, H&G, G&G Blue and White Fish,” does not list the food safety hazard of pathogen growth. The plan lists an intended use for some of the fishery products as b(4) Consequently, pathogen growth is a reasonably likely hazard because the products will not be cooked prior to consumption.
- 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 revised HACCP plan provided in your August 22nd response entitled, “Fresh, H&G, G&G Blue and White Fish,” intended for your scombrotoxin (histamine) forming species of fish, does not list a critical limit value associated with the “Internal CBT temperature” at the “Receipt of FP at Processing Plant” (CCP1) critical control point to control histamine. FDA recommends monitoring to ensure that internal temperatures are at or below 40°F (4.4°C) at receipt.
- Because you chose to include a corrective action plan in your HACCP plan, your described corrective action must be appropriate, to comply with 21 CFR 123.7(b). However your corrective action plan listed in your HACCP plan provided in your August 22nd response at the “Receipt of FP at Processing Plant” critical control point to control histamine (i.e., in the “Sensory examination” related portion of the critical control point) is not appropriate. Specifically, your firm’s corrective action fails to include remedial controls (e.g. chill and hold the affected lot; conduct histamine testing on a minimum of 60 fish and rejecting the lot if histamine in any fish exceeds 50 ppm; and discontinuing the use of the supplier until evidence is obtained that the identified harvesting and onboard practices have been improved). Conducting sensory testing alone on all of the fish is inadequate.
For additional information regarding FDA’s recommended controls for the hazards and controls discussed above, please refer to Chapters 7 of the Fish and Fisheries Products Hazards and Controls Guidance: Fourth Edition, which can be found on FDA’s web site at:
You should respond in writing within thirty (30) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. Your response should include documentation, such as a copy of any revised HACCP plans at least five (5) product days worth of monitoring records to demonstrate that you have implemented the revised plan, and other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before the 30 days, you should explain the reason for your delay and state when you will correct any remaining violations. 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 regulation, and the Good Manufacturing Practice regulation (21 CFR 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 Food and Drug Administration, Attention: Standra Purnell, Compliance Officer, Office of Compliance, Division of Enforcement, Food Adulteration Assessment Branch HFS-607, 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Standra Purnell via email at firstname.lastname@example.org.
Division of Enforcement
Office of Compliance
Center for Food Safety
and Applied Nutrition