Dr Gumbo's New Orleans Cuisine, Inc. 3/21/13
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New Orleans District
404 BNA Drive
Building 200 – Suite 500
Nashville, TN 37217
Telephone: (615) 366-7801
FAX: (615) 366-7802
March 21, 2013
WARNING LETTER NO. 2013-NOL-09
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
James L. Kangas, Owner
Dr. Gumbo’s New Orleans Cuisine, Inc.
1997 Surgi Drive
Mandeville, Louisiana 70448-2233
Dear Mr. Kangas:
On February 5-7, 2013, a U.S. Food and Drug Administration (FDA) investigator inspected your seafood processing facility, located at 1997 Surgi Drive, Mandeville, Louisiana. We found you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations
, Part 123, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations
, Part 110 (21 CFR 123 & 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 which complies 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 frozen, heat and serve seafood entrees 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 Products Hazards & Controls Guidance through links on FDA's Internet home page at www.fda.gov
We have received your response dated February 26, 2013. The following includes our assessment of the documents provided in your response packet.
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 plans for Crawfish Julie Sauce, Shrimp and Okra Gumbo, Shrimp and Corn Soup, Shrimp Creole, Shrimp Etouffee, and St Stevie Sauce do not list the critical control point of refrigerated storage for controlling the food safety hazard of pathogen survival and toxin formation.
You explain in your February 26, 2013, response you purchased and installed a temperature data logger in the cooler and included refrigerator storage in your HACCP plan. You did not provide a copy of your revised HACCP plan.
2. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b). However, your firm does not have a HACCP plans for Crawfish Julie Sauce, Shrimp and Okra Gumbo, Shrimp and Corn Soup, Shrimp Creole, Shrimp Etouffee, and St Stevie Sauce to control the food safety hazard of Clostridium botulinum.
You explain in your February 26, 2013, response you included the hazard associated with product in plastic bags in your HACCP plan. You also report you are using preprinted bags with proper frozen storage and thawing instructions. You did not provide a copy of your revised HACCP plan and the labeling.
3. You must verify your HACCP plan is adequate to control food safety hazards which are reasonably likely to occur, to comply with 21 CFR 123.8(a). However, your firm failed to verify adequacy of the critical limit of (b)(4) for Crawfish Julie Sauce, Shrimp and Okra Gumbo, Shrimp and Corn Soup, Shrimp Creole, Shrimp Etouffee, and St Stevie Sauce at the cooking critical control point to control pathogen survival and toxin formation. Specifically, you failed to calibrate the probe thermometer quarterly at two or more temperature points against a standard reference thermometer.
You explain in your February 26, 2013, response you changed your HACCP plan verification process on the kettle/cooking log thermometer and will renew the thermometer as necessary. You did not provide your HACCP plan and failed to provide the frequency or conditions which will necessitate replacing the thermometer.
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.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline 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 that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, please explain the reason for the delay and state when the corrections will be made.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR 123) and the Current Good Manufacturing Practice regulation (21 CFR 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Section 743 of the Act [21 USC 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 USC 379j-31(a)(2)(B)]. FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Please send your reply to the U.S. Food and Drug Administration, Attention: Mark W. Rivero, Compliance Officer, at the address above. If you have questions regarding any issues in this letter, please contact Mr. Rivero at (504) 832-1290, extension 1103.
Patricia K. Schafer
New Orleans District