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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Signature Flight Support 13-Dec-01

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration

Dallas District

4040 North Central Expressway

Dallas, Texas 75204-3145

December 13, 2001

Ref: 2002 -DAL-WL-07

WARNING LETTER

CERTIFIED MAIL

RETURN RECEIPT REQUESTED

Ms. Elizabeth Haskins

CEO and President

Signature Flight Support

201 South Orange Avenue

Orlando, FL 32801

Dear Ms. Haskins:

During an inspection of your airline support facility, Signature Flight Support, 7515 Lemmon Avenue, Dallas, Texas, on October 30, 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 suitable backflow prevention device at the potable water

hydrant with an attached hose located at Hangar K. The hose attached to

this hydrant was not of potable water grade quality with a quick connect and

did not have a nozzle guard. It was soiled and lying on a dirty floor.

2. Failure to have suitable backflow prevention devices to protect the potable

water supply at the non-potable hydrant with an attached hose at the dump

site station and Hanger E West Side Hydrant with attached hose.

3. Failure to have a handwash sign posted in the male employee bathroom

facilities.

4. Dirt was observed in the hose storage compartment for the potable water

cart.

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 Dallas 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.

Sincerely,

Michael A. Chappell

District Director