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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

American Eagle Airlines, Inc. 09-Jul-01

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

 


Food and Drug Administration
Dallas District
3310 Live Oak Street
Dallas, Texas 75204-6191

July 9, 2001

Ref: 2001 -DAL-WL-30
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. Peter Bowler, President
American Eagle Airlines, Inc.
4333 Amen Carter Boulevard
Ft. Worth, Texas 76155

Dear Mr. Bowler:

During an inspection of your airline support facility, American Eagle Airlines, Inc., 5401 North Martin Luther King Blvd., Lubbock, Texas, June 27, 2001, our investigator documented deviations from Title 21, Code of Federal Regulations (CFR) Part 1250.

Our inspection revealed significant insanitary conditions, including:

1.Failure to have a backflow prevention device at the potable water hydrant with an attached hose. This potable water hydrant source is used as a non-portable water source for the deicing truck mix preparation and is also used to fill blue water for the lavatory cart.

2.The potable water cart lacks an identification label stating "Drinking Water Only".

3.Personnel who handle waste disposal also handle potable water for the aircraft.

4.The nozzle size for the potable/non-potable water source is the same and the hose attached lacks a nozzle guard. The hose used for the potable/nonpotable water source is "garden grade". The potable water cart hose nozzle was stored on a dirty surface without coupling.

5.The men?s bathroom hand wash sink is soiled and a strong urine odor was noted coming from the bathroom.

6.Employees use the male or female hand wash sinks to clean coffee carafes.

The carafes and airplane coffee urns are not sanitized properly and there are no sanitizing strips for testing the sanitizing solution concentration. The aircraft coffee urn is not washed.

This letter is not intended to be an all-inclusive list of deficiencies at your airline support facility. It is your responsibility to ensure adherence to each requirement of the regulations.

A list of Inspectional Observations (FDA-483) was issued to and discussed with a Responsible individual at the Lubbock location. A copy of the FDA-483 is enclosed for your reference. Please address each observation in your response letter. As a result of this inspection, your firm is being placed on "provisional" status. You should take prompt action to correct these deviations and ensure that future violations do not recur. Failure to correct these critical violations can result in further action by FDA. Your airline support facility may be placed on "Not-Approved" status following the current "provisional" status, if future similar violations occur. It is your responsibility to assure that all of your airline support locations are in compliance with the regulations.

You should notify this office in writing, within fifteen(15) days of receipt of this letter, stating the specific steps you have taken to correct the aforementioned violations. Your reply should be directed to Gwen Gilbreath, Compliance Officer, at the above letterhead address. Your response letter dated June 28, 2001 was received, however, your response was not adequate and did not address each of the deficiencies. The investigator informed you during the inspection that you should advise the FDA what type of backflow device was installed and what procedures will be put in place to test the device.

We also need to know what you did to solve the issue of the non-potable water source for deicing trucks and lavatory carts being connected with the potable water. We do acknowledge the corrections made regarding the cart and hose.

Sincerely,

/s/
District Director