Inspections, Compliance, Enforcement, and Criminal Investigations
AirTran Airways 18-Sep-01
DEPARTMENT OF HEALTH AND HUMAN SERVICE
Food and Drug Administration
New Orleans District
6600 Plaza Drive, Suite 400
New Orleans, LA 70127
September 18, 2001
WARNING LETTER NO. 2001-NOL-59
Mr. Joseph Leonard, Chairman, CEO
9955 AirTran Boulevard
Orlando, Florida 32872
Dear Mr. Leonard:
We conducted an inspection of your commissary, watering point, and waste service facilities located at 14035 Airport Road, Gulfport, Mississippi, on August31, 2001. The inspection was conducted under the authority of the Public Health Service Act (PHSA) and the Federal Food, Drug, and Cosmetic Act (the Act).
At the conclusion of the inspection, the Form FDA 483 (Inspectional Observations) and Form FDA 2528 (Inspectional Summary) were issued to Mr. Kevin D. Wilson, Supervisor, citing violations of the Interstate Conveyance Sanitation Regulations, Title 21, Code of Federal Regulations (CFR), Part 1250 (21 CFR 1250). During the inspection, the following violation was noted:
- Your potable water cart is not constructed or maintained in a manner that prevents contamination of the water. For example, rust was observed around the bottom drain and side seams of the potable water cart. In addition, dirt sediment and a dead mosquito-type insect was observed at the bottom of the cart filled with potable water.
The list of inspectional observations, identified above, is not intended to be an all-inclusive list of the deficiencies which may exist. As a result of these deficiencies, this facility has been classified as "Provisional". Another inspection will be conducted within 30 days to determine if these deficiencies have been adequately corrected. If acceptable corrections have been made, the facility will be returned to an "Approved" classification. If corrections are unacceptable, a "Not Approved" classification will be assigned. Airlines are prohibited from using aircraft service areas that have been classified as "Not Approved" in accordance with21 CFR 1250.60.
During the inspection, Mr. Wilson reported to our investigator that he would begin making corrections. You should take prompt action to correct these deficiencies. It is your responsibility to ensure that all requirements of the PHSA and the Act are being met. You should notify this office in writing, within 15 working days of receipt of this letter of the actions taken to correct the deficiencies and to prevent their recurrence.
Your response should be directed to Mark W. Rivero, Compliance Officer, at the above address.Sincerely,
Carl E. Draper
New Orleans District