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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Mr. Fish Seafood 23-Mar-06

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

Dallas District
4040 North Central Expressway
Dallas, TX 75204-3145


 


March 23, 2006

Ref: 2006-DAL-WL-17

Certified Mail
Return Receipt Requested

WARNING LETTER

James T. Norton, Owner
Mr. Fish Seafood
3322 E. Parker Road
Plano, TX 75024

Dear Mr. Norton:

We inspected your seafood storage facility, located at 4008 Commerce Street, Suite 204 and 205, Dallas, Texas 75226 from March 3-8, 2006. 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, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123& 110). Your firm is a warehouse which is a "processor" within the meaning of the Seafood HACCP Regulations, 21 CFR 123.3(I). 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 pasteurized crabmeat is adulterated, in that it has been prepared, packed, or held under insanitary conditions whereby it 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:

You must conduct, or have conducted for you, a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and you must have a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a), and (c). However, your firm does not have a HACCP plan for the storage of canned pasteurized crabmeat to control the food safety hazard of Clostridium botulinum toxin formation.

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.

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.

Your reply should be directed to the Food and Drug Administration at the above letterhead address, Attention: Sherrie L. Krolczyk, Compliance Officer. If you have questions regarding any issues in this letter, please contact Sherrie L. Krolczyk at 214-253-5312.

Sincerely,

/S/

Michael A. Chappell
Dallas District Director