Inspections, Compliance, Enforcement, and Criminal Investigations
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