Gourmet Cuisine, Inc. 1/30/13
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Dallas District|
4040 North Central Expressway
Dallas, Texas 75204-3128
January 30, 2013
Mr. Claude Bergeron, Chief Executive Officer
Le Duff America, Inc.
12201 Merrit Drive, Suite 900
Dallas, TX 75251
Dear Mr. Bergeron:
We inspected your seafood processing facility Gourmet Cuisine, Inc., located at 214 S. Town East Blvd, Mesquite, TX 75149 on August 22, 2012 through September 11, 2012. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that 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 U.S.C. § 342(a)(4). Accordingly, your Lobster Bisque soup is adulterated, in that it has been prepared, packed, or held under insanitary conditions whereby it 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, Fourth Edition (HACCP Guide) through links in FDA's home page at www.fda.gov.
Your significant violations were as follows:
1. You must have a HACCP plan that, at a minimum, lists the critical limits that 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 plan for Seafood Soups (Lobster Bisque) lists a critical limit at the Container Sealing critical control point that is not adequate to control pathogen introduction after cooking. Specifically, the critical limit of, “no visible cuts, tears, product in seal, leakage or other obvious defects,” does not identify the container seal specifications necessary for an adequate seal of the pouches used to package your Lobster Bisque.
We have reviewed your response to the FDA 483 dated October 01, 2012, which includes portions of a revised HACCP plan, and found the critical limit for the Container Sealing CCP of your revised Seafood Soup HACCP plan is inadequate. Although, your revised HACCP plan provided in your response added a reference for your critical limit, it still does not include container seal specifications.
For more information on critical limits associated with pathogen introduction after cooking, see Chapter 18 of the HACCP Guide.
Also, your firm’s revised HACCP plan for Seafood Soups (Lobster Bisque) lists a monitoring procedure at the Container Sealing critical control point that is not adequate to control pathogen introduction after cooking. Specifically, the monitoring procedures do not include requirements for detailed examination of containers (destructive testing).
We have reviewed your response to the FDA 483 dated October 01, 2012 where you indicated you conduct destructive testing by sending the product through a (b)(4). The procedure you describe is not an adequately detailed examination of the container (destructive testing), in that it does not provide the pouch seal specifications and evidence showing adequate pressure is applied to the pouches to ensure the appropriate seal strength has been achieved. Additionally, although your response letter describes pressure testing of the sealed pouches, this testing is not included in the revised HACCP plan you provided.
For more information on monitoring procedures for controlling introduction of pathogens after cooking, see Chapter 18 of the HACCP Guide.
2. Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plan for Lobster Bisque at the Finished Product Labeling critical control point to control undeclared allergens is not appropriate. Your corrective action plan fails to address how your firm will regain control of label operations after a critical limit deviation. Specifically, your corrective action does not include actions to correct the cause of the deviation, such as correction of your label generation software and/or equipment used to print labels for your seafood soup products.
We have reviewed your response to the FDA 483 and found the corrective action listed in your revised Seafood Soups HACCP plan’s Finished Product labeling critical control point does not include provisions to correct your label generation systems.
3. You must fully document in your records all corrective actions taken, to comply with 21 CFR 123.7(d). However, you did not document that a corrective action was taken when you deviated from your controls for Lobster Bisque at the Finished Product Labeling critical control point to control undeclared food intolerance substances such as sulfites.
On August 22, 2012, your firm identified approximately (b)(4) cases of Lobster Bisque that were manufactured on August 21, 2012 and were mislabeled with labels that did not declare sulfites. On August 22, 2012, your firm segregated and relabeled (b)(4) of those cases. Your firm did not adequately document the corrective actions taken.
We have reviewed your response to the FDA 483 dated October 01, 2012 and found it is inadequate. Specifically, the record of corrective action you provided entitled “Deviation /Non-Conformance Report” dated August 27, 2012 appears to be a summary of actions that was created several days after the fact, rather than a contemporaneous record of corrective actions. This summary also does not include the identification and amount of affected product, and does not provide details of all corrective actions taken to correct the mislabeled Lobster Bisque products manufactured on August 21, 2012.
For more information on corrective actions for controlling undeclared food intolerance substances, see Chapter 19 of the HACCP Guide.
In addition, our inspection found your Lobster Bisque and Maryland Crab Soup contain ingredients, such as sherry wine, that contain sulfiting agents. During the inspection, the investigators requested copies of testing for sulfite concentration in the Lobster Bisque and Maryland Crab Soup but test results were not provided. The labels you provided for the products, during the inspection state “May Contain Sulfites” in the ingredients. Sulfites must be declared as an ingredient in the product if the concentration of sulfites is 10 parts per million (ppm) or greater (21 CFR 101.100(a)(4)). Please provide the requested test results and copies of the most current product labels that show you are meeting the critical limit for the “Finished Product Labeling” critical control point of your Seafood Soups HACCP plan.
Further, during our inspection your staff indicated your seafood soup products are not packaged foods under 21 CFR 1.20, and were therefore not subject to the label and labeling requirements for ingredient declaration. Section 403(i)(2) of the Act, 21 U.S.C. § 343(i)(2) required labeling of food unless otherwise exempt by 21 CFR 101.100. Our inspection found neither your Lobster Bisque nor Maryland Crab Soup are exempt from Section 403(i)(2) of the Act, 21 U.S.C. § 343(i)(2).
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.
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, you should explain the reason for your delay and state when you will correct any remaining violations.
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 Part 123). 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 U.S.C. 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 U.S.C. 379j-31(a)(2)(B)).
For a domestic facility, 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 Food and Drug Administration, Attention: Jeff R. Wooley, Compliance Officer, 4040 N. Central Expressway, Suite 300, Dallas, TX 75204. If you have questions regarding any issues in this letter, please contact Jeff R. Wooley, Compliance Officer at 214-253-5251.
Reynaldo R. Rodriguez, Jr.
Dallas District Director