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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Atlantic Southeast Airlines 02-May-08

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

Public Health Service
Food and Drug Administration

 

Kansas City District
Southwest Region
11630 West 80th Street
Lenexa, Kansas 66214-3340

Telephone: (913) 752-2100


May 2, 2008

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

WARNING LETTER AND NOTICE OF PROVISIONAL STATUS

Ref. KAN 2008-07

Brad Holt, President & Chief Operating Officer
Atlantic Southeast Airlines
100 Hartsfield Centre Parkway, Suite 800
Atlanta, GA 30354

Dear Mr. Holt:

This letter serves as your formal notification that the U.S. Food and Drug Administration (FDA) has classified your watering point, located at Mid-Continent Airport, Wichita, Kansas, as "Provisional." On March 6 & 7, 2008, an FDA investigator conducted an inspection of your facility in Wichita, Kansas, consisting of an aircraft watering point for Delta Connection airplanes. This inspection was conducted under the authority of the Public Health Service Act (PHS Act) to determine your compliance with applicable sections of the Interstate Conveyance Sanitation regulations (21 CFR Part 1250). These regulations were promulgated pursuant to Section 361 of the PHS Act (42 U.S.C. § 264). Regulations promulgated under this section are necessary to prevent the introduction, transmission, or spread of communicable diseases. This inspection revealed a significant deviation from 21 CFR Part 1250, under the PHS Act. Based on this finding, your watering point is classified as "Provisional".

At the conclusion of the inspection, the FDA investigator issued list of inspectional observations (Form FDA 483) to Albert Jackson, the station manager. As documented on this form (copy enclosed), the following is the significant violation at your watering point, on which we based the "Provisional" classification:

All servicing equipment and other appurtenances necessary for delivery of drinking and culinary water to a conveyance must be designed, constructed, maintained and operated in such a manner as to prevent contamination of the water, as required by 21 CFR 1250.67(a). However, the investigator observed that the water in the water cart was not free of contamination because sediment, including paint chips, was observed. Inside the water cart. This presence of sediment indicates that the water cart is not adequately maintained, flushed and sanitized with sufficient frequency to ensure potable water is delivered to the aircraft.

The inspectional observation, identified above, is not intended to be an all-inclusive list of the conditions observed at your facility. It is your responsibility to ensure adherence with all requirements of the regulations at this facility, and any other facilities involving interstate travel and sanitation under your control.

Based on the inspectional finding, we are classifying your facility as "Provisional." A "Provisional" classification means that the facility may continue to operate; however, significant correction of violations must be made. FDA will re-inspect this facility to determine its classification. If significant corrections are not made the time of the next inspection, FDA will reclassify the facility as "Non-Approved" for carrier use. We note that land and air conveyances engaged in interstate traffic must obtain potable water for drinking and culinary purposes from watering points approved by the FDA (21 CFR 1240.80).

Please advise this office within fifteen (15) days of the receipt of this letter regarding the measures you have implemented to correct the violations. Your response should include a discussion of any delays you foresee in achieving correction, and a deadline by which correction can be expected. Please direct your response to Nadine Nanko Johnson, Compliance Officer, at the address listed above.

Sincerely,

/S/

John W. Thorsky
District Director

Enclosure (FDA 483)

cc: Mr. Richard H. Anderson, CEO
Delta Air Lines, Inc.
P.O. Box 20706
Atlanta, GA 30320-6001

Mr. Albert W. Jackson
Delta Connection Station Manager
2299 Airport Rd.
Wichita, KS 67209