Inspections, Compliance, Enforcement, and Criminal Investigations
LSG SkyChefs DEN 235 12/10/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
Denver District Office
6'" Ave and Kipling Street
Denver Federal Center. Bldg 20
P O. Box 25087
Denver, CO 80225-0087
December 10, 2009
Ref#: DEN-10-04 WL
WARNING LETTER AND NOTICE OF PROVISIONAL STATUS
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Ms. Sondra Lehman
Chief Operating Officer
North American Region
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." Your airline customers will be notified of this change in classification. Between September 17 and October 6, 2009, FDA conducted an inspection of your airline catering facility located at 27280 E. 75th Avenue, Denver, Colorado. This comprehensive inspection was conducted under the authority of the Public Health Service Act (PHS Act) to determine your compliance with applicable sections of the Interstate Conveyance Sanitation regulations (21 CFR Part 1250). These regulations were promulgated pursuant to Section 361 of the PHS Act (42 USC § 264). Regulations promulgated under this section are necessary to prevent the introduction, transmission, or spread of communicable diseases. This inspection revealed significant deviations from 21 CFR Part 1250, under the PHS Act. Based on these findings, your airline catering facility is classified as "Provisional."
At the conclusion of the inspection, on October 6, 2009, the FDA investigator issued a list of Inspectional Ohservations (FDA-483) to your firm. As documented on this form (copy enclosed), 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
• To comply with 21 CFR 1250.32(a), all food-handling operations must be accomplished so as to minimize the possibility of contaminating food, drink, or utensils. However, our investigators observed the following:
• Employees handling food with bare hands or with unwashed gloved hands
• Water dripping from the ceiling into equipment/utensil cleaning areas
• Gaps from 1-2.5 inches under garbage room doors, receiving dock doors, and outbound dock area doors
• Standing water in the garbage room
• Accumulation of debris in various areas such as in the ice pit, dairy cooler, dish machine area, and automatic cart wash area
• Holes in wall surfaces, creating areas for insect and vermin harborage
• Debris and standing liquid inside the automatic cart wash machine
• To comply with 21 CFR 1250.33(c), after bactericidal treatment, utensils must be stored and handled in such a manner as to prevent contamination before reuse. However, our investigators observed wet containers in nested stacks in the pots and pans ware-washing room and in the bot kitchen areas. Leaving containers stacked in a wet condition promotes the growing of bacteria, which could lead to contamination of your finished product.
• To comply with 21 CFR 1250.30(d), all plumbing must be designed, installed, and maintained so as to prevent contamination of the water supply, food, and food utensils.
However, our investigators observed water hoses stored with nozzles resting on the floor.
• To comply with 21 CFR 1250.39, watertight, readily cleanable, nonabsorbent containers with close-fitting covers must be used to receive and store garbage. However, our
investigators observed brown leaking fluid draining from at least two garbage bins, apparently creating standing pools of the brown fluid amongst trash debris under/around
the bins in the garbage room.
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.
We have reviewed your October 7, 2009 response and acknowledge the corrective actions that you have already taken. Specifically, you have upgraded your environmental monitoring program in an effort lo control Listeria monocytogenes and have provided FDA with results from recent testing. You have also taken corrective steps to control for cockroaches and other insects, including updating your pest control plan, implementing new cleaning schedules, and repairing holes in the walls of your facility. Your firm's corrective actions and the results of these actions will be verified during our next inspection.
The inspectional observations, identified above, are not intended to be an all-inclusive list of the conditions observed at your facility. It is your responsibility to ensure adherence with all requirements of the regulations al this facility, and any other facilities involving interstate travel and sanitation under your control.
Based on these inspectional findings, a "Provisional" classification bas been assigned to your facility for a 30 day period, after which time a re-inspection will be conducted. A "Provisional" classification means that the facility may continue to operate; however, significant correction of violations must be made. If the conditions of food production and operation of the facility are not improved and verified by FDA by the time of the next inspection, then your facility will be classified as "Use Prohibited" or "Not Approved." Airlines may not obtain their food from a "Use Prohibited" or "Not Approved" source.
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.
A copy of this Warning Letter is being sent to users of the LSG SkyChefs DEN 235, Denver, Colorado facility.
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.
H. Thomas Warwick, Jr.
Director, Denver District