Inspections, Compliance, Enforcement, and Criminal Investigations
LSG Sky Chefs 28-Aug-08
Department of Health and Human Services
Public Health Service
New England District
August 28, 2008
VIA Federal Express
Sondra Lehman, CEO
LSG Sky Chefs
6191 N. State Hwy., 161
Irving, Texas 75038
Dear Ms. Lehman:
We inspected your seafood processing facility, located at 2 Airport Park Road, East Granby, Connecticut on May 16, 19 and 20, 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, 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 2.1 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 Tilapia Fillets and Shrimp meals are adulterated, in that 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 in FDA's home page at www.fda.gov.
You must have a HACCP plan that lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(c)(1). However, your firm's HACCP plan for tilapia fillets and shrimp does not list the food safety hazard of Clostridium botulinum toxin formation which is reasonably likely to occur in raw fish that is modified atmosphere packaged regardless of the oxygen level at the time of packaging. We note that you attach a time/temperature indicator to every package. TTIs may be an appropriate means of controlling the hazard of C. botulinum toxin formation. A TTI should be designed to alert the consumer that an unsafe time and temperature exposure has occurred that may result in C. botulinum toxin formation. FDA recommends that you take the steps necessary to ensure that the TTIs are fit for the intended purpose and functional at the time of use and that your HACCP plan include appropriate critical limits and monitoring procedures to ensure that the TTIs are properly used.
As stated above, TTIs are intended to alert the consumer that a product may be unsafe. FDA does not recommend that TTIs be used to monitor temperature during storage or transit. Instead, FDA recommends a critical limit of 38°F and continuous monitoring of temperature with visual checks for all storage critical control points for seafood products in modified atmosphere packages.
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) 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.
Please send your reply to the Food and Drug Administration, Attention: Bruce R. Ota, Compliance Officer, Food and Drug Administration, One Montvale Avenue, Fourth Floor, Stoneham, Massachusetts 02180. If you have questions regarding any issues in this letter, please contact Mr. Ota at 781-596-7762.
Michael R. Kravchuk
Acting District Director
New England District
Michael Mincey, Operations Manager
2 Airport Park Road.
East Granby, Connecticut 06026