WARNING LETTER
Eugene Airport MARCS-CMS 519504 —
- Recipient:
- Eugene Airport
United States
- Issuing Office:
- Seattle District Office
United States
| |
Seattle District Office 22215 261h Avenue SE, Suite 210 Bothell, Washington 98021 |
June 1, 2017
OVERNIGHT DELIVERY
SIGNATURE REQUIRED
In reply, refer to WL SEA 17-16
Timothy M. Doll, Airport Director
Eugene Airport
28855 Lockheed Drive
Eugene, Oregon 97402
WARNING LETTER AND NOTICE OF PROVISIONAL STATUS
Dear Mr. Doll:
This letter serves as your formal notification that the United States Food and Drug Administration (FDA) has changed the classification of your aircraft servicing area located at 28855 Lockheed Drive, Eugene, Oregon from “Approved” to “Provisional.” Your airline customers will be notified of this change in classification.
On January 10, 2017, FDA conducted an inspection of your facility, consisting of aircraft servicing areas and watering points. 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 Code of Federal Regulations Part 1250 (21 CFR 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 a significant violation of 21 CFR 1250, under the PHS Act. Based on these findings, your aircraft servicing area is classified as “Provisional.”
At the conclusion of the inspection, the FDA investigator issued a Form FDA-483, Inspectional Observations, to your firm. As documented on the Form FDA-483, the significant violation observed was a follows:
To comply with 21 CFR 1250.70(a), adequate toilet, washroom, locker, and other essential sanitary facilities must be readily accessible for use by employees and adjacent to places or areas where land and air conveyances are serviced, maintained, or cleaned. These facilities shall be maintained in a clean and sanitary condition at all times. Furthermore, 21 CFR 1250.75(c) requires all persons who have handled soil cans or other containers which have come in contact with human wastes to wash their hands thoroughly with soap and warm water and to remove any garments which have become soiled with such wastes before engaging in any work connected with the loading, unloading, transporting or other handling of food, water or ice. However, our investigator observed the following conditions at the lavatory dump station: hand- sanitizer and no hand wash sink, soap, or sanitary towels.
We acknowledge your letter, received January 24, 2017, written in response to the FDA-483 issued at the conclusion of the inspection. In your response, you confirm that hand-sanitizer is located at the lavatory dump station, and that hand washing stations are located in the office space for all three airline ground handling companies operating from the Eugene Airport. In your response, you identify that hand wash facilities are located in the airline space at a distance of between 260 and 300 feet from the lavatory dump station.
Anti-septic hand-sanitizer products are an adjunct to hand-washing, and not a replacement for hand-washing. The reason for this is that ethanol hand-sanitizers are not effective against fecal-oral route viruses, such as norovirus and Hepatitis A virus, and difficult to remove from the hands in the presence of fecal material. The availability of anti-septic hand-sanitizers co-located with the lavatory dump site is not adequate to address the public health concern. In addition, a distance in excess of 260 feet is not considered to be readily available when evaluating the location of a hand wash sink relative to a lavatory dump station. An employee in search of a hand wash sink after removing human waste from an airplane has to open with his/her hands at least one door used by other personnel who may onboard water or food to airplanes, or flight attendants. The same inspectional observation was communicated to your firm at the conclusion of our February 2014 inspection. For these reasons, we find your written response inadequate to address the aforementioned violation.
The violation identified above is not intended to be an all-inclusive list of the violations observed at your facility. It is your responsibility to ensure adherence with all requirements of FDA regulations at your aircraft servicing areas and watering points, and any other conveyances or facilities involving interstate travel and sanitation under your control.
Based on this inspectional finding, a “Provisional” classification has been assigned to your facility for a 30 day period, after which time a re-inspection will be conducted. “Provisional” classification means that the facility may continue to operate; however, significant correction of the violation must be made. If significant corrections are not made by the time of the next inspection, FDA will reclassify the facility as “Non-Approved” for carrier use. We note that land and air conveyances engaged in interstate traffic must use servicing areas approved by FDA (21 CFR 1250.60).
You should respond in writing within fifteen (15) working days of receiving this letter of the steps you have taken to bring your firm into compliance with the law. Your response should include each step you have taken or will take to correct the violation. You should also include in your response any documentation or other useful information that would assist us with evaluating your corrections. If you cannot complete all corrections before you respond, state the reason for the delay and when you will complete the corrections.
Please send your written response to the U.S. Food and Drug Administration, Seattle District, 22215 26th Avenue SE, Suite 210, Bothell, Washington, 98021-4421, to the attention of LCDR Cynthia White, Compliance Officer. If you have any questions about this letter, please contact LCDR White at (425) 302-0422.
Sincerely,
/S/
Miriam R. Burbach
District Director
cc: Honorable Mayor Lucy Vinis
City of Eugene, Oregon
125 East 8th Avenue, Second Floor
Eugene, Oregon 97401
Oregon Department of Agriculture
Food Safety Division
635 Capitol Street NE
Salem, Oregon 97310-0110
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