Inspections, Compliance, Enforcement, and Criminal Investigations
Culinaire Incorporated 11/3/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
Denver District Office
Bldg. 20-Denver Federal Center
P.O. Box 25087
6th Avenue & Kipling Street
Denver, Colorado 80225-0087
November 3, 2009
RETURN RECEIPT REQUESTED
Mr. Bernard A. Cohen, President/CEO
1111 West Exposition Avenue
Denver, Colorado 80223
Ref: DEN-10-02 WL
Dear Mr. Cohen:
We inspected your firm, Culinaire Incorporated, located at 1111 West Exposition Avenue, Denver, Colorado on June 10-12, 15, 17-18, 22, 2009. Our inspection found that your firm has serious deviations from the seafood Hazard Analysis and Critical Control Points (HACCP) Regulation, Title 21, Code of Federal Regulations, Part 123 [21 CFR Part 123]. In accordance with 21 CFR § 123.6(g), failure of a processor to have and implement a HACCP plan that complies with this. section or otherwise operate in accordance with the requirements of this part, renders the fishery products processed there 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 fish and fishery products are adulterated, in that 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. You may find the Act, the Seafood HACCP Regulation and FDA's Fish and Fisheries Products Hazards and Controls Guidance: 3rd. Edition, June 2001 (the Hazard Guide) through links in FDA's home page at www.fda.gov.
We acknowledge receipt of your response dated July 10, 2009, which included descriptions of corrections you have made and copies of HACCP plans for:
1. "Lobster, crab, shrimp, scallops, Fish, Smoked Salmon canape (Fully Cooked)";
2. "Herbed Salmon, Poached Scallops, Herbed Halibut, Blackened Catfish (Fully Cooked)";
3. "crab stuffed shrimp, Lobster, shrimp, scallops, fish (Not fully Cooked) Cook Before Serving"; and
4. "Coconut shrimp - Raw Cook before serving".
We have completed our review of your response and have determined that your response is inadequate to address all the violations that FDA documented at your firm. We continue to have the following concerns.
1. You must have a HACCP plan that, at a minimum, lists the critical limits that must be met at each of the critical control points, to comply with 21 CFR Part 123.6(c)(3). A critical limit is defined in 21 CFR Part 123.3(c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a clinical 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 "Lobster, crab, shrimp, scallops, Fish, Smoked Salmon canape (Fully Cooked)" and "Herbed Salmon, Poached Scallops, Herbed Halibut, Blackened Catfish (Fully Cooked)"submitted with your July 1alii response do not list adequate critical limits at the:
a. "Cooking/Lethality CCP-JB" critical control points to control pathogen growth. Specifically, your plans list a cook process that achieves an internal temperature (b)(4) This cook process is inadequate to control the pathogens identified in your plans as Salmonella, Listeria monocytogenes and Clostridium botulinum.
In addition, it appears from the observations made during our inspection, that your smoked salmon canape product does not receive a "cook" process. This product is described as a ready-to-eat canape that is assembled from previously processed ready-to-eat materials, such as previously processed smoke salmon. Consequently, this canape product should likely not be included in this HACCP plan. You may want to conduct a separate hazard analysis on this product, as. well as similar products to determine whether there is a need for a separate HACCP plan to cover your ready-to-eat products that receive no cook, to control pathogen growth during, for example, thawing of frozen products and/or during any periods of extended refrigerated storage.
b. "Cooler Storage CCP-1B" critical control points to control pathogen growth. Specifically, your firm lists "Internal Product Temperature not to exceed (b)(4) in these plans. However, our investigation revealed that your firm holds/stores ready-to-eat fish and fishery products in your cooler for time periods that exceed (b)(4) In addition, your monitoring procedures at the cooler storage critical control points are not consistent with these critical limits. Specifically, your monitoring procedures indicate that you intend to monitor (b)(4) basis. Since it was revealed during the inspection that your firm has a continuous monitoring chart recorder on your cooler, we suggest that you set a critical temperature limit of 40°F at the cooler storage critical control points. We also suggest that you conduct a daily check of the temperature record and a daily check of the equipment to ensure that proper temperatures are maintained.
2. In addition, for those products that pose a hazard for allergens because they are manufactured with ingredients such as wheat, eggs, milk, etc., we suggest including a critical control point in those HACCP plans to address the issue of undeclared allergens. We recommend conducting label reviews of the finished product labels to ensure that the
allergenic substances are properly declared in the ingredient statements.
We may take further action if you do not promptly correct these violations. For instance, we may initiate regulatory action without further notice. Such actions may include the initiation of a seizure action against your products and/or an action to enjoin your firm from operating.
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 these deviations. You should include in your response documentation such as your HACCP plans, copies of all related monitoring records and corrective actions, calibration 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 and all applicable regulations.
Please send your reply to the Food and Drug Administration, Attention: Carolyn A. Pinney, Compliance Officer, at the above letterhead address. If you have any questions regarding any issue in the letter, please contact Carolyn A. Pinney at (303) 236-3024.
H. Thomas Warwick,Jr.
Denver District Director