Inspections, Compliance, Enforcement, and Criminal Investigations
Cuisine Solutions, Inc. 03-Sep-08
Department of Health and Human Services
Public Health Service
Baltimore District Office
September 3, 2008
Via Facsimile and Certified Mail
RETURN RECEIPT REQUESTED
CMS # 28727
Mr. Stanislas Vilgrain
President and CEO
Cuisine Solutions, Inc.
85 South Bragg Street, Suite 600
Alexandria, VA 22312
Dear Mr. Vilgrain:
We inspected your seafood processing facility, located at 4106 Wheeler Avenue, Alexandria, VA, on June 30th thru July 1st of 2008. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations (CFR) Part 123 (21 CFR 123). In accordance with 21 CFR 1216(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 seared salmon 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 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 "Cooked Seafood" lists a critical limit, "Minimum internal temperature during cooking shall reach 60°C (140°F)", at the "cooking" critical control point that is not adequate to control C. botulinum growth and toxin formation. Clostridium botulinum is able to produce spores and, in this state, the pathogen is very resistant to heat. Your critical limit of 140°F is not sufficient to prevent the spores from germinating and producing toxin. Moreover, your plan does not specify any cook time. Please be advised that we recommend a cook temperature and-time combination adequate to achieve a 6D reduction in the numbers of the C. "botulinum organisms. For more information on cooking and the hazard of C. botulinum please refer to Chapters 13 and 16 of the Fish and Fisheries Products Hazards and Controls Guidance: 3rd Edition.
2. You must conduct or have conducted for you a hazard analysis to determine whether there are food safety hazards that 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 plan for "Cooked Seafood" does not list the critical control point of "cooling" for controlling the food safety hazard of pathogen contamination after cooking. Introduction of pathogens into the finished product after cooking is a concern because contaminated cooling water can enter through poorly formed or defective container closures during container cooling performed in a water bath. Your seared salmon is packaged in its finished product container prior to cooling in water. For more information on introduction of pathogens following cooking please refer to Chapter 18 of the Fish and Fisheries Products Hazards and Controls Guidance: 3rd Edition.
We received your letter dated July 25, 2008 responding to the FDA-483. Your response does not adequately address all of the observations noted in the FDA-483; those areas which this office continues to view as violations are listed above.
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.
Please 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) and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Finally, a number of sanitation observations were noted and presented to you on the FDA-483. At that time, our investigator also discussed with you the importance of having a person on your staff that is trained in seafood HACCP. We request that you schedule a meeting with Mr. Sooter to discuss these observations and address corrections.
Please send your reply to the U.S. Food and Drug Administration, Attention: Mr. Kirk D. Sooter, Compliance Branch Director, 6000 Metro Drive, Suite 101, Baltimore, MD 21215. If you have questions regarding any issues in this letter, please contact Mr. Sooter at (410) 779-5412.
cc: Ms. Sylvie Porphire
Vice President of Quality Assurance
Cuisine Solutions, Inc.
4106 Wheeler Avenue
Alexandria, VA 22304