Here are portions of the FDA “WARNING LETTER AND NOTICE OF PROVISIONAL STATUS”
Ms. Sondra Lehman
, Chief Operating Officer
North American Region
LSG SkyChefs
6191 N. State Highway 161
Irving, Texas 75038
Dear Ms. Lehman:
This letter serves as your formal notification that the U.S. Food and Drug Administration (FDA) has changed the classification of your airline catering facility from "Approved" to "Provisional." … As documented on this form, the following are the significant violations at your airline catering facility on which we base the "Provisional" classification:
• To comply with 21 CFR 1250.30(a), all places where food is prepared, served, or stored must be constructed and maintained as to be clean and free from flies and other vermin. However, our investigators observed numerous live roaches, dead roaches, and other insects, as well as food, and other debris, in various locations, including the following:
• Cart wash area – Live and dead roach-like insects too numerous to count (TNTC);
• Silverware station – At least 40 live roaches as well as other insects;
• The hot kitchen – At least eight dead and one live roach insects were observed in and around the walls of the hot kitchen;
• Repack area – Live roaches (TNTC), as well as ants;
• Pots and pans warewashing room – At least four live and dead roaches, flies;
• Dish machine wash area – At least 13 dead roaches inside the machine loading area and 31 or more dead nearby the machine
• Wash area – At least four live roaches on walls and floors. …
In addition, during the inspection, our investigators collected environmental swab sub samples from various locations within your firm’s processing facility to be analyzed for the pathogen Listeria monocylogenes. Our FDA laboratory analyses of these environmental samples (FDA Sample #531908) revealed that three swab sub samples collected from floor locations in the hot kitchen area. were found positive for Listeria monocytogenes. …
You should take prompt action to correct the deficiencies. It is your responsibility to ensure that all requirements of the PHS Act, the Federal Food, Drug, and Cosmetic Act, and their implementing regulations, are being met. You should notify this office in writing, within 15 working days of receipt of this letter, of any additional specific steps you have taken to correct each of the violations. Your response should include a discussion of any delays you foresee in achieving correction, and a deadline by which correction can be expected. …
Please send your reply to the food and Drug Administration, Attention: Nancy G. Schmidt, Compliance Officer, P.O. Box 25087, Denver, CO 80225. If you have any questions regarding this letter, please contact Ms. Schmidt at (303) 236-3046.
Sincerely,
H. Thomas Warwick, Jr.
Director, Denver District