Inspections, Compliance, Enforcement, and Criminal Investigations
AMR Corp./American Airlines, Inc. 15-Sep-03
Public Health Service
|San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
RETURN RECEIPT REQUESTED
Our Reference: 3003383323
September 15, 2003
Gerard J. Arpey
President and Chief Executive Officer
AMR Corporation/American Airlines, Inc.
P.O. Box 619616
DFW Airport, TX 75261-9616
Dear Mr. Arpey:
On July 15, 2003, FDA conducted an inspection of American Eagle Airlines, Inc. located at 200 Fred Kane Drive, Suite 101, Monterey, California, which provides aircraft watering point and lavatory waste service at Monterey Peninsula Airport. The observation made during the inspection revealed that the facility is in violation of Section 361 of the Public Health Service Act and the Interstate Conveyance Sanitation regulations at Title 21, Code of Federal Regulations, Part 1250 (21 CFR Part 1250). FDAs observation was listed on Form FDA 483, Inspectional Observations, which was issued to and discussed with Frank F. Schultz, General Manager. A Form FDA 2528, Inspection Summary - Airline Service Area or Watering Point Sanitation, was also provided to Mr. Schultz. Copies of both documents are enclosed for your ready reference.
During the inspection, the following observation was noted:
The potable water system used to fill the lavatory waste cart has no backflow prevention (21 CFR 1250.67).
The inspectional observation, identified above, is not intended to be an all-inclusive list of deficiencies. It is your responsibility to assure adherence with all applicable statutes and regulations enforced by FDA.
Based on the inspectional findings, we are classifying your facility as Provisional for interstate carrier use for a period of thirty (30) days. A Provisional classification means that the facility may continue to operate; however, significant correction of violations must be made by the expiration date. On or about that date, a re-inspection of this facility will be conducted to assure that corrections meet FDA requirements. If significant corrections are not made by the time of the next inspection, this facility will be reclassified as Not Approved for carrier use. Assignment of Not Approved status for food service facilities means that food and beverages from this facility may not be used by interstate conveyances until the violations have been corrected and the facility has been re-inspected by FDA.
You should notify this office in writing, within fifteen (15) working days of the receipt of this letter, of the specific steps that you have taken to prevent a recurrence of the cited deficiencies. Your response should include a discussion of any delays you foresee in achieving correction and a deadline by which correction can be expected. Your response should be directed to:
Randall P. Zielinski
Interstate Travel Specialist
Food and Drug Administration
143 1 Harbor Bay Parkway
Alameda, CA 94502-7070
You may wish to fax your response to Mr. Zielinski at (510) 337-6703.
Dennis K. Linsley
San Francisco District