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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

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