| Public Health Service Food and Drug Administration |
PHILADELPHIA DISTRICT |
Department of Health and Human Services
WARNING LETTER AND NOTICE OF PROVISIONAL STATUS
11-PHI-20
August 9, 2011
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Mark Gale, Chief Executive Officer
Philadelphia International Airport
8000 Essington Avenue
Terminal D/E, 3rd Floor
Executive Offices
Philadelphia, PA 19153-3805
Dear Mr. Gale:
This letter serves as your formal notification that the U.S. Food and Drug Administration (FDA) has changed the classification of your watering point and aircraft servicing area from "Approved" to "Provisional." Your airline customers will be notified of this change in classification. On May 2 through May 27, 2011, FDA conducted an inspection of your facility, consisting of aircraft servicing areas and watering points, located at the Philadelphia International Airport, 8000 Essington Avenue, Philadelphia, PA. 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 violations of 21 CFR Part 1250, under the PHS Act. Based on these findings, your watering point and aircraft servicing area is classified as "Provisional."
At the conclusion of the inspection, the FDA investigator issued a list of Inspectional Observations (Form FDA-483), and an Inspection Summary - Airline Service Area or Watering Point Sanitation(Form FDA 2528) to your firm (copies attached). As documented on the Form FDA-483, the following are the significant violations:
1. To comply with 21 CFR 1250.67(a), all servicing area piping systems, hydrants, taps, faucets, hoses, buckets, and their appurtenances necessary for delivery of drinking and culinary water to a conveyance must be designed, constructed, maintained, and operated in such a manner as to prevent contamination of the water. However, our investigator found at the water cabinets and dump station that:
a) There are no testable backflow prevention devices in line to any potable water cabinets located outside Terminal (b)(4) or at Terminal (b)(4) gates (b)(4).
b) There is no backflow prevention device dedicated to each potable water cabinet located at Terminal (b)(4) near gates (b)(4) through (b)(4)
c) There is no back flow prevention device between the hose used to wash down the floor in the lavatory dump station or the hose used to rinse out the interior of the lavatory carts and the hand wash sink in either lavatory dump station.
d) Annual testing is not performed for the reduced pressure zone assembly device (serial number (b)(4) on the (b)(4) pipe which supplies all (b)(4) potable water cabinets for use by commercial aircraft at Terminal (b)(4)
e) Annual testing is not performed for the reduced pressure zone assembly devices in line to the potable water piping supplying domestic water and potable water cabinets for use by commercial aircraft at Terminals (b)(4) serial number (b)(4) and at Terminal (b)(4)(serial number (b)(4)
2. 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, and cleaned. These facilities shall be maintained in a clean and sanitary condition at all times. However, our investigator observed the following conditions in the lavatory dump stations, which house triturators on the (b)(4) and (b)(4) sides of the airport: no warm running water at the lavatory sink, no soap for hand washing, and no paper towels.
3. To comply with 21 CFR 1250.75(a), at servicing areas and at stations where land and air conveyances are occupied by passengers the operations shall be so conducted as to avoid contamination of such areas and stations by human wastes. However, the grate identified as used to cover the triturator was clogged with soiled toilet paper waste and was leaning against the exterior of the lavatory dump station near Terminal (b)(4) Additional grating around the triturator in the lavatory dump station near Terminal (b)(4) also had toilet paper collecting on it. Further, toilet paper was observed on the floor of the lavatory dump station.
We acknowledge your response letter dated June 24, 2011; however, you did not provide documentation of your corrective actions. We will verify the adequacy of your corrective actions at the next inspection of your facility.
The inspectional observations, identified above, are 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 these inspectional findings, a "Provisional" classification has 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 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 obtain potable water for drinking and culinary purposes from watering points approved by FDA (21 CFR 1240.80) and must use servicing areas approved by FDA (21 CFR 1250.60).
We also note that to comply with 21 CFR 1250.62, plans for construction or major reconstruction of sanitation facilities at servicing areas must be submitted to FDA for review of the conformity of the proposed facilities with FDA regulations. Plans for the construction of Terminal (b)(4) and the extension of Terminal (b)(4) were not submitted to FDA for review. In the future, you must submit all plans for construction or major reconstruction of sanitation facilities at servicing areas to FDA.
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 that 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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