Inspections, Compliance, Enforcement, and Criminal Investigations
Tropical Seafood 10/4/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New Orleans District
404 BNA Drive
Building 200 – Suite 500
Nashville, TN 37217
Telephone: (615) 366-7801
FAX: (615) 366-7802
October 4, 2012
WARNING LETTER NO. 2013-NOL-01
UNITED PARCEL SERVICE
Delivery Signature Requested
Son V. Tran, Owner
Tropical Seafood, Inc.
245 Chester Lee Street
Lockport, Louisiana 70374
Dear Mr. Tran:
On July 11-13, 16, and 17, 2012, a U.S. Food and Drug Administration (FDA) investigator inspected your seafood processing facility, located at 24291 Highway 1, Golden Meadow, Louisiana. We found 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), and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110). 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), Title 21, United States Code (USC), Section 342(a)(4). Accordingly, your shrimp is adulterated because 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 on FDA's Internet home page at www.fda.gov.
We received your response, dated July 26, 2012, concerning our investigator’s observations noted on the FORM FDA 483 (FDA 483), List of Inspectional Observations, issued to you on July 17, 2012. Our evaluation of your response is discussed after the item noted below. Significant violations listed on the FDA 483 include, but are not limited to, the following:
1. You must conduct or have conducted a hazard analysis for each kind of fish and fishery product you produce to determine whether there are food safety hazards which are reasonably likely to occur and you must have and implement a written HACCP plan to control any food safety hazards which are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b). However, your firm does not have a HACCP plan for shrimp to control the food safety hazards of environmental contaminants and sulfites.
Your HACCP plan provided with your letter dated July 26, 2012, fails to list the seafood products. If you choose to control environmental chemical contaminants, pesticides, or sulfites at the receiving step, you must receive a certificate from the supplier of the product. In addition, the HACCP plan fails to list the documents used to monitor each batch of product received.
We may take further action if you do not promptly correct these noted violations. For instance, we may take further action to seize your product 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 steps you have taken to correct the noted violations. You should include in your response documentation such as your revised HACCP plan and verification records, or other useful information to assist us in evaluating your corrections. If you cannot complete all corrections within 15 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 violations at your facility. You are responsible for ensuring your processing plant operates in compliance with the Act, the seafood HACCP regulation, 21 CFR 123, and the Current Good Manufacturing Practice regulation, 21 CFR 110. You have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 U.S.C. 379j-1(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Please send your reply to the U.S. Food and Drug Administration, Attention: Mark W. Rivero, Compliance Officer, at the address above. If you have questions regarding any issues in this letter, please contact Mr. Rivero at (504) 832-1290, extension 1103.
Patricia K. Schafer
New Orleans District