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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Delta Air Lines, Inc. 03-Mar-04

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

Cincinnati District Office
Central Region
6751 Steger Drive
Cincinnati, OH 45237-30977
Telephone: (513) 679-2700
FAX: (513) 679-2761

March 3, 2004

WARNING LETTER
CIN-04-20536

Via Federal Express

Frederick W. Reid
President and Chief Operating Officer
Delta Air Lines, Inc.
1030 Delta Boulevard
Atlanta, GA 30320

Dear Mr. Reid:

This letter serves as your formal notification that the U.S. Food and Drug Administration (FDA) has classified your aircraft servicing facility located at 600 Terminal Drive #19, Louisville International Airport, Louisville, Kentucky, as "Provisional" for interstate carrier use.

On December 5, 2003, FDA conducted an inspection of your Comair servicing facility, including your watering equipment and waste disposal area. The inspection found that you have serious deviations from the Interstate Conveyance Sanitation regulations (21 CFR 1250) issued under the authority of the Public Health Service Act. The servicing facility is not being operated and maintained so as to prevent the spread of communicable disease as required for approval under 21 CFR 1250.61. The deficiencies include:

1. Your servicing areas must be operated and maintained as to prevent the spread of communicable diseases, to comply with 21 CFR 1250.63. However, the inspection revealed that lavatory cart 902 had spilled waste on the outside of the dump hose and in various locations around the cart. Also, lavatory chemicals were found on the outside of the cart near the filling inlet. In addition, the discharge hose was damaged and appeared to be leaking.

2. Your watering equipment must be maintained and operated in such a manner as to prevent contamination of the water, to comply with 21 CFR 1250.67. However, the inspection revealed that rust debris was found at the bottom of water cabinets 81084 and 81085. Also, the service end of the potable water hose in cabinet 81085 was not equipped with a ball or disk to prevent it from coming in contact with the ground during use.

3. Your employee conveniences must be maintained in a clean and sanitary condition at all times, to comply with 21 CFR 1250.70. However, the inspection revealed that the men’s toilet facility was not so maintained. Trash was on the floor of the stalls and the floor under the urinals was in disrepair making cleaning difficult.

The above objectionable conditions were pointed out and explained to William B. Ward II, Customer Services Manager. A written list of objectionable conditions was issued to Mr. Ward immediately after the inspection.

The deficiencies found at your servicing facility could contribute to the spread of communicable diseases. Based on the inspectional findings, we are classifying your facility as "Provisional" for interstate carrier use. A "Provisional" classification means that the facility may continue to operate; however correction of deficiencies must be made by the time the facility is re-inspected. If significant corrections are not made by the time of the next inspection, the facility will be reclassified as "Not Approved" for carrier use. A classification of "Not Approved" prohibits the use of your water and waste disposal services by interstate conveyances until the violations have been corrected and the facility has been re-inspected by FDA.

Please advise us in writing within fifteen (15) working days of the receipt of this letter of the actions you have taken to address the deficiencies. Your response should include an explanation of each step being taken to correct the deficiencies and prevent their recurrence. Include copies of any available documentation demonstrating that corrections have been made.

Your reply should be directed to the attention of Deborah Grelle, Director of Compliance, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237 (513) 679-2700 extension 160.

Sincerely,

/s/

Carol A. Heppe
District Director

cc:

Randy D. Rademacher,
President
Comair Holdings, Inc.
77 Comair Boulevard
Erlanger, KY 41018