Inspections, Compliance, Enforcement, and Criminal Investigations
Andre Oran Leger, Inc. Chez Francois Seafood 15-Apr-05
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|New Orleans District
6600 Plaza Drive, Suite 400
Now Orleans. LA 70127
April 15, 2005
WARNING LETTER NO. 2005-NOL-17
Mr. Andre O. Leger, Owner/President
Andre Oran Leger, Inc. Chez Francois Seafood
139 Tissington Street
Lafayette, Louisiana 70501
Dear Mr. Leger:
On February 1 - 3, and 14, 2005, an investigator from the U.S. Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, located at 139 Tissington Street, Lafayette, Louisiana. We found you have serious deviations from the Seafood Hazard Analysis and Critical Control Point (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 to comply 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). You may find the Act and the Seafood HACCP regulations through links in FDA's Internet home page at http://www.fda.gov. Accordingly, your crawfish tail meat, boiled whole crawfish, and crab meat 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.
The deviations were as follows:
- You must conduct a hazard analysis to determine whether food safety hazards are 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 (b). However, your firm did not have a HACCP plan for cooked crabmeat to control the food safety hazards of pathogen survival and pathogen growth and toxin formation.
- You must conduct a hazard analysis to determine whether food safety hazards are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points, to comply with 21 CFR 123 .6 (a) and (c) (2) . A critical control point is defined in 21 CFR Part 123.3(b) as a "point, step, or procedure in a food process at which control can be applied and a food safety, hazard can as a result be prevented, eliminated, or reduced to acceptable levels." However, your firm's HACCP plans for fresh and frozen crawfish tail meat and for whole boiled crawfish did not list the critical control point of overnight cooler storage for controlling the food safety hazards of pathogen growth and toxin formation . Also, those plans did not list the critical control points of labeling to control the food safety hazard of Clostridium botulinum (C. botulinum) toxin formation.
We particularly are concerned with your failure to identify and to implement controls for C. botulinum toxin formation in your HACCP plans for crawfish. To prevent toxin production by C. botulinum, vacuum-packaged crawfish tail meat and whole boiled crawfish must be maintained in a frozen condition until immediately before use by the consumer. Also, they should be labeled with adequate storage instructions (such as "Important, keep frozen until used, thaw under refrigeration immediately before use").
Please note, in place of identifying "Labeling" as a critical control point, you have another option for frozen, vacuum-packaged product under HACCP. The product description on your HACCP plans may identify the product as "vacuum packed frozen crawfish tail meat, labeled `Important, keep frozen until used, thaw under refrigeration immediately before use."
- You must implement the monitoring and recordkeeping procedures listed in your HACCP plans, to comply with 21 CFR 123.6(b). However, your firm did not follow the monitoring procedure nor record monitoring observations at the boiling critical control point (CCP), to control the pathogen survival hazard listed in your HACCP plans for crawfish tail meat. Specifically, on February 1, 2005, you did not follow the monitoring procedures to "Visually check time & temp" for batch [redacted] which reached an internal temperature of [redacted] and batch [redacted]which reached an internal temperature of only [redacted]. Also, on February 1, 2005, you did not enter cook times for batches [redacted] through [redacted].
- You must conduct a hazard analysis to determine whether food safety hazards are reasonably likely to occur and have a HACCP plan which, at a minimum, lists the food safety hazards reasonably likely to occur, to comply with 21 CFR 123.6(a) and (c)(1). A food safety hazard is defined in 21 CFR 123.3(f) as "any biological, chemical, or physical property that may cause a food. to be unsafe for human consumption." However, your firm did not list the food safety hazards of pathogen growth and toxin formation at the chill, peeling, and packing CCPs in the fresh and frozen crawfish tail meat HACCP plans, and at the chill, packing, storage, and distribution CCPs in the frozen whole boiled crawfish HACCP plan.
- You must maintain sanitation control records which, at a minimum, document monitoring and corrections to comply with 21 CFR 123.11(c) . However, your firm did not maintain sanitation monitoring records for safety of the water which contacts food or food contact surfaces, or is used in the manufacture of ice ; prevention of cross-contamination; protection of food, foai packaging material, and food contact surfaces from adulteration ; and, exclusion of pests required for the processing of picked crabmeat, crawfish tail meat, and whole boiled crawfish.
We are aware during the inspection you made a verbal commitment to correct the deviations, and we received your letter dated March 2, 2005, describing corrections you made in response to some of our inspectional observations. However, your letter and its attachments do not sufficiently address all the deficiencies at your facility. For example, inadequacies in your new peeled crabmeat HACCP plan include inappropriate critical limits at the backing, overnight storage, peeling and packing critical control points, and monitoring frequencies at the chill and packing critical control points. Also, your response does not address implementing the monitoring and recordkeeping procedures listed in your HACCP plans for crawfish tail meat. You do not adequately address the food safety hazard of C. botulinum toxin formation in your HACCP plans for vacuum-packed crawfish tail meat and whole boiled crawfish.
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 deviations . You should include in your response documentation such as copies of sanitation control records, corrected label for whole boiled crawfish, your food facility registration number, or other useful information to assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect you will explain the reason for your delay and state when you will correct any remaining deviations.
We may take further action if you do not promptly correct the violations described in this letter. These actions may include seizing your products and/or enjoining your firm from operating.
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, the Seafood HACCP regulations and the Current Good Manufacturing Practice regulations, 21 CFR 110. You also have a direct responsibility 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 the above address or at telephone number 504-253-4519.
H. Tyler Thornburg
New Orleans District