| Public Health Service |
New Orleans District Telephone: (615) 366-7801 |
Department of Health and Human Services
October 30, 2007
WARNING LETTER NO. 2007-NOL-03
FEDERAL EXPRESS
OVERNIGHT DELIVERY
Darrel J . Rivere, Owner
A La Carte Foods, Inc.
278 Ideal Street
Paincourtville, Louisiana 70391
Dear Mr. Rivere:
We inspected your seafood processing facility, located at 278 Ideal Street, Paincourtville, Louisiana on July 24 - 26, 2007 . We found you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations (21 CFR), Part 123, and the Current Good Manufacturing Practice (CGMP) regulation for foods, 21 CFR 110. In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan, complying with this section or otherwise operate in accordance with the requirements of 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 United States Code (USC) 342(a)(4)]. Accordingly, your "Not Fully Cooked and Not Shelf Stable", "Heat Treated but not Shelf Stable", and your "Heat Treated but Not Fully Cooked-Not Shelf Stable" seafood products are adulterated, because they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Product Hazards & Controls Guidance through links in FDA's Internet home page at www. fda.gov.
Your significant violations were as follows:
1. You must conduct a hazard analysis to determine whether there are food safety hazards which are reasonably likely to occur and have a HACCP plan which, 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 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 plan for products "Not Fully Cooked and Not Shelf Stable", which includes crab cakes and crab kickers, and your HACCP plan for products "Heat Treated but Not Fully Cooked-Not Shelf Stable," which includes crabmeat au gratin, do not list the critical control point of refrigerated storage of cooked seafood ingredients for controlling the food safety hazard of pathogen growth and toxin formation. The hazard of pathogen growth and toxin formation is associated with pasteurized canned crabmeat, an ingredient of some of the products manufactured under these HACCP plans. FDA recommends implementing controls which assure the product has not been exposed to temperatures above 40°F while in storage. These recommendations include monitoring the adequacy of the ice surrounding the product or continuous temperature monitoring of ambient temperature to control the growth of pathogens and toxin formation in cooked seafood products.
2. You must have a HACCP plan which, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123 .6 (c) (4). However, all your firm's HACCP plans for products "Heat Treated but Not Fully Cooked", "Heat Treated but not Shelf Stable" and "Not Fully Cooked-Not Shelf Stable" list a monitoring procedure of "Temperature in each box", at receipt of refrigerated, cooked seafood products which is not adequate to control the hazard of pathogen growth and toxin formation during transit. FDA recommends implementing controls which assure the product has not been exposed to unsafe conditions while in transit. These recommendations include monitoring the adequacy of the ice surrounding the product or continuous temperature monitoring of ambient temperature during transit to control the growth of pathogens and toxin formation in cooked seafood products.
3. You must have a HACCP plan which, at a minimum, lists the critical limits which must be met, to comply with 21 CFR 123.6(c)(3). A critical limit is defined in 21 CFR 123 .3(c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard." However, your firm's HACCP plans for multiple types of cooked seafood products list critical limits "[redacted] degrees F", "[redacted] degrees F", and "[redacted] degrees F" which are not adequate to control the hazard of pathogen survival through cooking. There is no indication as to whether these temperatures represent product temperatures (i.e. internal) or temperatures of the cooking apparatus. Furthermore, there is no "time" component listed in conjunction with the critical temperature limits. Please be advised when monitoring internal end-product temperatures, the Fish and Fisheries Products Hazards and Controls Guidance: 3rd Edition recommends employing a process authority to validate a process schedule to assure you are controlling the hazard of pathogen survival through processing and to ensure each piece in each batch receives an adequate cook process.
We may take further action if you do not promptly correct these violations. For instance, we may seize your products and/or enjoin your firm from operating.
Please respond in writing within fifteen (15) working days from your receipt of this letter outlining the specific things you are doing to correct these violations. You should include in your response documentation, such as HACCP and verification records, or other useful information which would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, state the reason for your delay and when you will correct any remaining violations.
We noted you have a HACCP plan for products which are not fully cooked and are not shelf stable. Please be advised FDA recommends manufacturers provide a cook adequate to control the pathogen(s) of concern to their products if the product might reasonably be consumed without a thorough cooking by the end user.
This letter may not list all the violations at your facility. You are responsible for ensuring your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR 123) and CGMP regulation (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: Karl L. Batey, Compliance Officer, at the above address. If you have questions regarding any issues in this letter, please contact Ms. Batey at (615) 366-7808.
Sincerely,
/S/
H. Tylhornburg
District Director
New Orleans District
Enclosure: Form FDA 483
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