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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Southwest Airlines, Inc. 27-Jul-01

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

 

Food and Drug Administration
Dallas District
4040 North Central Expressway
Suite 300
Dallas, Texas 75204

July 27, 2001

Ref: 2001 -DAL-WL-32
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Ms. Colleen Barrett
President and Chief Operating Officer
Southwest Airlines, Inc.
2702 Love Field Drive
Dallas, Texas 75235

Dear Ms. Barrett:

During an inspection of your airline support facility, Southwest Airlines, Inc., #1 Airport Drive, Little Rock National Airport, Little Rock, Arkansas, on July 3, 2001, our investigator documented deviations from Title 21, Code of Federal Regulations (CFR) Part 1250.

Our inspection revealed significant insanitary conditions, including:

  1. An employee bagging ice without washing his hands prior to the ice bagging.
  2. Ice scoops used for ice bagging are not sanitized.
  3. A brown substance was observed adhering to the inner walls of the large ice machine directly over stored ice.

4. The handwash sink, doubling as a dishwashing area, was soiled with a brown substance.

5. Test strips for checking sanitizing solution concentrations were not present.

6. The deicing hydrant, a non-potable water source, lacked a backflow prevention device.

7. Handwash signs are not present at the handwash sink in the ice machine room.

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 Little Rock, Arkansas, 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,

/s/

Michael A. Chappell

District Director