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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Syosset Seafoods Co 07-Feb-07

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, Texas 75204-3128


 

February 7, 2007

2007-DAL-WL-8

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. Michael R. Intondi, Owner
Syosset Seafoods Co.
2158 W. Northwest Highway, Suite 410
Dallas, TX 75220-4222

Dear Mr. Intondi:

We inspected you firm, Syosset Seafoods Co., located at 2158 W. Northwest Highway, Suite 41 Dallas, Texas, on January 19-23, 2007. 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 Regulation , Part 110 (21 CFR Parts 1238 110). In accordance with 21 CFR § 123.6(g), failure of a processor of fish and fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of 21 CFR 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, cooked crabmeat and fresh tuna are audit rated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered Injurious to health. You may find 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:

1. Pursuant to 21 CFR § 123.6(a), your firm is required conduct, or have conducted for it, a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur, and to identify the preventive measures that your firm will apply to control those hazards. Also, pursuant to 21 CFR § 123.6(b), your firm must have end implement a HAACP plan whenever a hazard analysis reveals one or more food safety hazard that are reasonably likely to occur.

However, your firm does not have a HACCP plan for pasteurized cooked crabmeat to control pathogen growth and toxin formation, and for fresh tuna to control histamine forming bacteria.

We acknowledge receipt of your letter dated January 25, 2007. We may take further action if you do not promptly correct this violation. For instance, we may initiate regulatory action without further informal notice. Such actions may include the initiation of a seizure action against your products and/or an action to enjoin your firm from operating.

Please respond in writing within 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 your HACCP plans, copies of all records that pertain to your HACCP plans,temperature monitoring records, and corrective actions or other useful information 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.

This letter may not list all of the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the Seafood HACCP Regulations, and the Good Manufacturing Practice regulations (21 CFR Part 110) You also have a responsibility to use procedures to prevent further violations o the Act and all applicable regulations.

Please send your reply to the Food and Drug Administration, Attention: Carolyn A. Pinney, Compliance Officer, at the above letter head address. If you have any questions regarding any issue in the letter, please contact Carolyn A Pinney at (214) 253-5220.

Sincerely,

/S/

Michael A. Chappell
Dallas District Director

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