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U.S. Department of Health and Human Services

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Enforcement Actions

Tuna Fresh, Inc. 03-Oct-01

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
New Orleans District
Southeast Region
6600 Plaza Drive, Suite 400
New Orleans, Louisiana 70127
Telephone: 504-253-4519
Facsimile: 504-253-4520

October 3, 2001
WARNING LETTERNO. 2002-NOL.-01
FEDERAL EXPRESS
OVERNIGHT DELIVERY

Mr. Larry B. Loga, Sr., President
Tuna "Fresh," Inc.
1501 Whitney Avenue
Gretna, Louisiana 70056

Dear Mr. Loga:

We inspected your firms, located at 40679 Highway 23 South, Boothville, Louisiana, on August 21 and 23, 2001, and 1501 Whitney Avenue, Gretna, Louisiana, on August 27-29 and September 4, 2001, and found that you have serious deviations from the Seafood Hazard Analysis Critical Control Point (HACCP) regulations, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). These deviations cause your domestic and imported fish to be in violation of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act). You can find this Act and the seafood HACCP regulations through links in FDA?s home page at www.fda.gov.

The deviations were as follows:

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 fresh, raw yellowfin tuna, mahi-mahi, wahoo, and escolar lists a critical limit, proper icing on the fish, at the receiving critical control point that is not adequate to control scombrotoxin formation. In addition, your firm?s HACCP plan for pompano, snapper, triggerfish, and amberjack lists a critical limit, proper icing and odor of the fish, at the receiving critical control point that is not adequate to control ciguatera fish poisoning.

You must have a HACCP plan that lists the food safety hazards that are reasonably likely to occur to comply with21 CFR 123.6(c)(l). However, your firm?s HACCP plan for amberjack does not list the food safety hazard of scombrotoxin formation.

You must have and implement written verification procedures for ensuring that the finfish you import into the United States is processed in accordance with HACCP principles to comply with 21 CFR 123.12(a)(2). However, your firm does not have product specifications for the imported tuna. In addition, your firm has not taken any affirmative steps to verify that the tuna you import has been processed in accordance with HACCP principles.

We may take action without further notice if you do not promptly correct these violations. For instance, we may seize your products and/or enjoin your firm from operating.

We are aware that during both of our inspection [redacted] General Manager, made verbal commitments to correct violations observed at your firms. However, please respond in writing within three weeks from your receipt of this letter, outlining the specific actions you are taking to correct these deviations and prevent their recurrence. You may wish to include in your response documentation such as copies of your verification procedures, imported fish specifications, fish temperature monitoring records, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections within the allotted time, we expect that you will explain the reason for your delay and state when you will correct any remaining deviations.

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 regulations and the Current Good Manufacturing Practice regulations. 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 Food and Drug Administration, Attention: Mr. Mark W. Rivero, Compliance Officer, at the address above. If you have questions regarding any issue in this letter, please contact Mr. Rivero at (504) 253-4519.

Sincerely,
Carl E. Draper
District Director
New Orleans District