| Public Health Service Food and Drug Administration |
PHILADELPHIA DISTRICT |
Department of Health and Human Services
WARNING LETTER
11-PHI-09
March 24, 2011
OVERNIGHT DELIVERY
RETURN RECEIPT REQUESTED
James P. Rankin, President and Chief Executive Officer
Air Wisconsin Airlines Corporation
W6390 Challenger Drive, Suite 203
Appleton, WI 54914
Dear Mr. Rankin:
On January 3 through 6, 2011, the U.S. Food and Drug Administration (FDA) conducted an inspection of (b)(4) of your passenger aircraft, located at 8500 Essington Avenue, U.S. Airways Express - Hanger 6, Philadelphia, PA, which operate in interstate travel between their home base in Wisconsin and twenty-six states in the U.S. and two Canadian provinces. 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 U.S.C. 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.
At the conclusion of the inspection, the FDA investigator issued a list of Inspectional Observations (Form FDA-483) to your firm. As documented on the Form FDA-483 (copy enclosed), the following are the significant violations noted on your aircraft:
1. To comply with 21 CFR 1250.38(a), toilet and lavatory facilities of suitable design and construction shall be provided for use of food-handling employees. However, on January 3, 2011, our investigator observed the lavatory to be placarded as "out of service" on aircraft (b)(4). The pilot presented our investigator with a maintenance log which indicated the lavatory had been "out of service" since 8:25 am on January 2, 2011. On January 4, 2011, our investigator returned to this aircraft, between flights, and observed that the "out of service" placard was still in place. On January 6, 2011, during the close out meeting with our investigator, it was reported that the lavatory had been repaired. We are concerned that the aircraft was operational for three days without operational toilet facilities and was repaired only as a direct result of our findings, and even then not for several days.
2. To comply with 21 CFR 1250.38(b), hand washing facilities for food-handling employees to wash their hands shall include soap, sanitary towels and hot and cold running water or warm running water in lieu of hot and cold running water. However, our investigator found that the temperature of the water in the lavatory sinks on aircraft (b)(4) and (b)(4) was cold to the touch.
3. To comply with 21 CFR 1250.38(c), toilet rooms shall be maintained in a clean condition. However, immediately following overnight cleaning, the toilet in aircraft (b)(4) was observed to be soiled. Further, our investigator observed what appeared to be "blue juice" chemical deodorizer on the floor in the lavatory of aircraft (b)(4) and (b)(4).
4. To comply with 21 CFR 1250.32(a), all food-handling operations shall be accomplished so as to minimize the possibility of contaminating food, drink, or utensils. However, our investigator observed that the handles of beverage carts, which food-handling employees must contact to access the beverages, were soiled and sticky to the touch on aircraft (b)(4) and (b)(4). In addition, our inspection of the beverage cart, following overnight cleaning on aircraft (b)(4) found the sleeve covering the metal handle to remain soiled and sticky to the touch.
5. To comply with 21 CFR 1250.30(d), all plumbing shall be so designed, installed, and maintained as to prevent contamination of the water supply, food, and food utensils. However, our investigator observed the cap for the potable water inlets "fore" and "aft," on multiple aircraft, to be soiled with a black substance. This was observed on the "aft" potable water inlets on aircraft (b)(4) and (b)(4) on the "fore" potable water inlet of aircraft (b)(4). Further, our investigator observed what appeared to be a moldy substance on the hot water spigots in the galleys of aircraft (b)(4) and (b)(4).
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 on all of your passenger aircraft, and any other conveyances or facilities involving interstate travel and sanitation under your control.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to enjoin your passenger aircraft from operating. 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.
In addition to the violations described above, we have the following comments.
• To comply with 21 CFR 1250.28, all ice coming in contact with food or drink shall be stored and handled in such manner as to avoid contamination. Our investigator observed that bagged ice arrives on the aircraft and is emptied, by flight attendants, into plastic lined metal trays on the beverage carts. The food grade quality of these lining bags could not be determined during the inspection. You should confirm that these lining bags are of food grade quality and allow for the handling of ice in such manner to avoid contamination.
• Our investigator noted that there were no certificates of sanitary construction posted on your aircraft. If certificates of sanitary construction have been issued by FDA for your aircraft, they must be prominently posted on the aircraft to comply with 21 CFR 1240.20.
Please notify this office in writing within fifteen (15) working days from your receipt of this letter of the specific steps you have taken to correct the violations described above. Include in your response documentation to show correction has been achieved. If you cannot complete all corrections before you respond, state the reason for the delay and when you will complete the corrections.
Your response should be sent to Lynn S. Bonner, Compliance Officer, at the address noted above. If you have any questions with regard to this letter, Ms. Bonner can be reached at 215-717-3074 or Lynn.Bonner@fda.hhs.gov.
Sincerely,
/S/
Kirk Sooter
District Director
Philadelphia District Office
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