Inspections, Compliance, Enforcement, and Criminal Investigations
Armand's Seafood 19-Jul-01
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
New Orleans District
6600 Plaza Drive, Suite 400
New Orleans, Louisiana 70127
July 19, 2001
WARNING LETTER 2001-NO-39
OVERNIGHT DELIVERYMr. Larry P. Armand, Owner
1142 Front Street
Cottonport, Louisiana 71327
Dear Mr. Armand:
We inspected your firm, located at 1142 Front Street, Cottonport, Louisiana on May 23,2001, 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 histamine-forming species of fish, such as amberjack, blue fish, blue runner, bonito, j ackfish, mackerel, blackfin tuna, and jack cravelle, and live crawfish to be in violation of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. You can find this Act and the seafood HACCP regulations through links in FDA?s home page at http://www. fda.gov.
The deviation was as follows:
- You must have a written HACCP plan to control any food safety hazards that are reasonably likely to occur to comply with21 CFR 123.6(b). However, your firm does not have a HACCP plan for scombrotoxin-forming species of fish to control that food safety hazard.
During the inspection, sanitation deficiencies were documented. The inspection showed:
- You have no sanitation control records for the period May 15 to 23,2001, during which time you processed fish, graded live crawfish, and stored seafood products;
- Your sanitation check lists, for the period March 23 to April 3,2001, do not document monitoring for employee health conditions nor for the exclusion of pests;
- At least 75 live flies were on and around mesh sacks of live crawfish in your grading/loading area on May 23, 2001; and,
- Equipment in your fish processing room showed inadequate cleaning after previous operations. For example, brownish residues were embedded in the gouges of the fiberglass cutting boards and were encrusted on the sides and top surface of the mechanical fish skinner. Also, fish scales and rust-colored residues remained on the bottom surface of each of the sink?s three compartments.
We may take action without further notice, if you do not promptly correct these violations. For instance, we may take action to seize your product(s) and./or enjoin your firm from operating.
We are aware that you made a verbal commitment for corrections to our investigator. However, 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 a HACCP plan and sanitation control records 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: Nicole F. Hardin, Compliance Officer at the above address. If you have questions regarding any issue in this letter, please contact Ms. Hardin at (504) 253-4519.
Patricia K. Schafer
Acting District Director
New Orleans District
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