Inspections, Compliance, Enforcement, and Criminal Investigations
Philadelphia International Airport Close out Letter 10/4/11
| Public Health Service Food and Drug Administration |
PHILADELPHIA DISTRICT |
Department of Health and Human Services
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
October 4, 2011
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:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 11-PHI-20 issued August 9, 2011. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Steven L. Carter
Director, Compliance Branch
Philadelphia District Office
| Public Health Service Food and Drug Administration |
| PHILADELPHIA DISTRICT 900 U.S. Customhouse 2nd and Chestnut Streets Philadelphia, PA 19106 Telephone: 215-597-4390 |
NOTICE OF APPROVED STATUS
September 8, 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:
On September 6 and 7, 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. The purpose of this inspection was to determine if corrective actions were implemented as a result of our June 9, 2011. Warning Letter (11-PHI-20) and "Provisional" classification. Our inspection confirmed that substantial corrective actions to the deviations listed in the Warning Letter were taken. In addition, your management informed our investigator that any remaining issues will be corrected within two weeks.
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 "Provisional" to "Approved". Your airline customers will be notified of this change in classification.
If you have any questions regarding this letter, please contact Lynn S. Bonner, Compliance Officer, at 215-717-3074 or Lynn.Bonner@fda.hhs.gov.
Sincerely,
/S/
Kirk Sooter
District Director
Philadelphia District Office
