Inspections, Compliance, Enforcement, and Criminal Investigations
Cajun Gold Catfish Processors, Inc. 24-Jul-01
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
New Orleans District
6600 Plaza Drive, Suite400
New Orleans, Louisiana 70127
WARNING LETTER NO. 2001-NOL-40
Mr. Charles E. Koehn, Owner
Cajun Gold Catfish Processors, Inc.
330 Elmwood Road
Lake Providence, Louisiana 71254-4324
Dear Mr. Koehn:
We inspected your firm, located at 330 Elmwood Road, Lake Providence, Louisiana on June 26 and 27, 2001, and found that you have serious deviations from the Seafood HACCP regulations Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). These deviations, some of which were previously brought to your attention, cause your catfish products to be in violation of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act). They are adulterated because they have been prepared, packed or held under conditions whereby they may become contaminated with filth. You can find this Act and the seafood HACCP regulations through links in FDA?s home page at http://www.fda.gov.
The deviations were as follows:
- 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(b). However, your firm does not have a HACCP plan for aquacultured catfish to control the food safety hazards of environmental chemicals and aquaculture drugs. This deviation was previously brought to your attention on the Form FDA 483 issued June 13,2000.
During the inspection, our investigator documented numerous insanitary conditions that also cause the product, whole gutted catfish, to be adulterated within the meaning of Section 402(a)(4) of the Act.
Our investigator documented conditions that facilitate unsanitary operations, which are associated with the construction and design of your facility. For example:
- Numerous holes and gaps in the exterior walls of the building provide a path directly into the processing area. This deviation was previously brought to your attention on the Form FDA 483 issued June 13, 2000; and,
- The raw sewage line is broken, allowing large amounts of solid waste to spill onto the surrounding grounds adjacent to the exterior wall of the processing facility. This deviation was previously brought to your attention on the Form FDA 483 issued June 13,2000.
Food processing equipment is not maintained in a sanitary condition to prevent food from becoming adulterated within the meaning of the Act. For example:
- The band saw blade used to remove the heads of catfish is rusted; and,
- The rotating metal hook rack used to hold whole catfish contains peeling paint and rust.
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.
Please respond in writing within three (3) weeks from your receipt of this letter. Your response should outline the specific things you are doing to correct these deviations. You may wish to include in your response documentation such as your HACCP plan, Catfish Producer Certification forms, and Live Fish Producer HACCP Visit forms 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 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 Good Manufacturing Practice regulations (21 CFR 11O).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: Mark W. Rivero, Compliance Officer, at the above address. If you have questions regarding any issue in this letter, please contact Mr. Rivero at (504)253-4519.
Carl E. Draper
New Orleans District
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