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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Belle River Seafood 22-Mar-05

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

Public Health Service
Food and Drug Administration

 

New Orleans District
Southeast Region
8600 Plaza Drive, Suite 400
New Orleans, LA 70127

Telephone: 504-253-4519
FAX: 504-253-4520


March 22, 2005

WARNING LETTER NO. 2005-NOL-15

FEDERAL EXPRESS
OVERNIGHT DELIVERY

Paula A McDaniel, Co-Owner
Belle River Seafood
1225 Highway 70
Pierre Part, Louisiana 70339

Dear Ms. McDaniel:

On January 11-12, 2005, a United States Food and Drug Administration (FDA) investigator inspected your seafood processing facility, located at 1225 Highway 70, Belle River, Louisiana. The FDA investigator issued a Form FDA 483, Inspectional Observations, to you at the conclusion of the inspection, describing serious deviations from the Seafood Hazard Analysis Critical Control Points (HACCP) regulations, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). In accordance with 21 CFR 123.6(g), failure of a processor to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of this part, renders the 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., Section 342(a)(4). Accordingly, your stuffed seafood products are adulterated, as they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health . You may find the Act and the Seafood HACCP regulations through links in FDA's Internet home page at
http://www.fda.gov.

The deviations are as follows:

  • You must conduct a hazard analysis to determine whether there are food safety hazards reasonably likely to occur and you must have a written HACCP plan to control any food safety hazards reasonably likely to occur to comply with 21 CFR 123.6(a) and (h). However, your firm does not have a HACCP plan for your prepared, stuffed seafood products to control the food safety hazards of pathogen growth, allergens, and additives.

  • You must provide all mandatory records for official review at reasonable times to comply with 21 CFR 123.9(c). However, you were not able to provide any temperature monitoring records for the storage of your seafood products after July 5, 2004

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 from operating.

We acknowledge, at the close of the inspection, you made a verbal commitment to correct the observed deficiencies ; however, we have found deviations from the Seafood HACCP regulation in previous inspections of your facility. Please respond in writing, within 15 working days from your receipt of this letter, explaining the specific steps you have taken to correct these deviations. You should include in your response documentation, such as a HACCP plan for your prepared seafood products, copies of your temperature monitoring records, or other useful information to assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect you to 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 your processing plant operates in compliance with the Act, Seafood HACCP regulations, and the Current Good Manufacturing Practice regulations, 21 CFR 110. You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

Please send your reply to the U.S. Food and Drug Administration, Attention: Nicole F. Hardin, Compliance Officer, at the address above. If you have questions regarding any issue in this letter, please contact Ms. Hardin at (504) 253-4519.

Sincerely,

/S/

Patricia K. Schafer
Acting District Director
New Orleans District