Inspections, Compliance, Enforcement, and Criminal Investigations
Tropic Fish and Vegatable Center, Inc. 21-Nov-01
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda. CA 94502-7070
VIA FEDERAL EXPRESS
Our Reference: 2952462
November 21, 2001
Glenn H. Tanoue, President
Tropic Fish and Vegetable Center, Inc.
1020 Auahi Street, Bldg #3
Honolulu, Hawaii 96814
Dear Mr. Tanoue:
On July 25 and 27, 2001, we inspected your seafood processing facility and found that you have serious deviations from the Seafood HACCP regulations in Title21, Code of Federal Regulations, Part 123 (21 CFR 123). These deviations cause your Tuna and Other Scombroid Finfish and your imported Mahi Mahi and Tuna to be adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), in that the products have been prepared, packed, and held under insanitary conditions whereby they may be rendered injurious to health. You may find the Act and the Seafood H.ACCP regulations through hiss in FDA?s home page at www.fda.gov. See attached handout, which gives information on how to obtain the Fish & Fisheries Products Hazards & Controls Guidance, 3rd edition, June 2001.
Your serious HACCP deviations we, as follows:
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). However, your firm?s HACCP plan for tuna and other histamine-producing species lists a combination of critical limits at the receiving critical control point that is not adequate to control histamine. Your HACCP plan lists the critical limits of internal temperature (40?F), sensory evidence of proper shipboard handling, and compliance with importer specifications as one combination of critical limits at receiving. The recommended critical limits for secondary processors of histamine-producing fish at receiving is either:
All lots received are accompanied by transportation records (e. g., temperature recording chart) that show the fish were held at or below 40? F throughout transit.
For fish held under ice or other cooling media at the time of delivery--there is an adequate quantity of ice or other cooling media to completely surround the product.
2. You must have a HACCP plan that lists monitoring procedures for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your firm?s HACCP plan for tuna and other histamine-producing species lists a monitoring procedure at the cooler storage critical control point that is not adequate to control histamine.
Your firm?s HACCP monitoring procedure for the cooler storage critical control point is an electronic system that continuously monitors temperature of the cooler storage.
The monitoring procedure is inadequate because the alarm system is set to activate when the internal temperature of the cooler reaches 47?F. The alarm should be set at a temperature known to insure that the internal temperature histamine-producing fish is maintained at 40?F or below.
3. You must have product specifications that are designed to ensure that the fish and fishery products you import are not injurious to health, to comply with 21 CFR 123.10. However, your firm does not have a product specification for mahi mahi and tuna imported from[redacted].
4. You must implement an affirmative step which ensures that the fish and fishery products you import are processed in accordance with the seafood HACCP regulation, to comply with 21 CFR 123.10. However, your firm did not mahi mahi and tuna manufactured by [redacted].
For your information, although it is not required by the FDA HACCP regulation, your firm has chosen to include corrective actions in your HACCP plan for histamine producing species. If you include corrective actions in your 13ACCP plan, the corrective actions must be adequate to control the hazard(s) listed in the plan. However, the corrective actions cited in both the receiving and cooler storage critical control point of your HACCP plan are inadequate and should be modified if they remain part of the plan.
Chapter 7 of the FDA Fish & Fishery Products, Hazards & Controls Guide, third edition, lists recommendations for adequate corrective actions to control histamines.
At the conclusion of the inspection, the deviations were listed on Form FDA 483 (Inspectional Observations) and discussed with you. A copy of this form is enclosed for your ready reference. This list is not meant to be an all-inclusive list of violations. You are responsible for ensuring that your processing facility operates in compliance with the Act, the Seafood HACCP regulations, and the Good Manufacturing Practice regulations (21 CFR 110).
We acknowledge receipt of a facsimile dated August 3, 2001 from Mr. Chuck Turner, which includes ( 1) Importer Written Verification Procedures; (2) Seafood Product Safety Specification for Mahi; and (3) Certificate from the [redacted] Ministry of Agriculture and Livestock, Animal Health Division, Meat and Inspection Department to [redacted].
The Product Safety Specification for Mahi is inadequate in that it only lists the hazards associated with Mahi but does not ensure Mahi is not adulterated. The Certificate identifies the processor, [redacted]. However, item #5 of the Form FDA 483 submitted to you on July 27, 2001 states that you need an affirmative step for mahi mahi and tuna imported from [redacted]. Please explain the relationship between [redacted].
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your products and/or enjoin your firm horn operating.
In addition, we may not provide certificates to your firm for export of your products to European Union (EU) countries if you do not correct these deviations.
Please 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 the deviation. You may wish to include in your response documentation 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.
Your response should be directed to: Ms. Harumi Kishida, Compliance Officer, U.S. Food and Drug Administration, 1431 Harbor Bay Parkway, Alameda, CA 94502-7070.
If you have any questions regarding any issue in this letter, please contact Ms. Kishida at (510) 337-6824.Sincerely,
Dennis K. Linsley
San Francisco District