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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Ogden Aviation Services 10-May-02

Department of Health and Human ServicesDepartment of Health and Human Services            Public Health Service

Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
Telephone: 510-337-6700

WARNING LETTER
VIA FEDERAL EXPRESS

May 10, 2002
Our Reference Number: FE11000135355

Malcolm Bromham, Senior Vice President
Ogden Aviation Services
4627th Avenue
New York, NY 10018

Dear Mr. Bromham,

On March 20,2002, FDA conducted an inspection of your facility located at San Francisco International Airport, San Francisco, CA, which provides potable water and aircraft waste service to various airlines at San Francisco International Airport. The observations made during the inspection revealed that your facility is in violation of the Public Health Service Act and the Interstate Conveyance Sanitation regulations at Title 21, Code of Federal Regulations, Part 1250 (21 CFR 1250). FDA?s observations were listed on Form FDA 483, List of Inspectional Observations, a copy of which was provided to, and discussed with, Mr. Arnold Menis, Operations Manager, at the conclusion of the inspection.

During the inspection the following observations were noted:

1. The backflow prevention device is not attached to the potable water line at the lavatory service area. The hose is attached to this potable water line and the hose end is stored on the ground while not in use.

2. The lavatory service truck, LV1 is not identified.

3. The lavatory service hose is not capped while not in use.

The list of inspectional observations, identified above, is not intended to be an all-inclusive list of the conditions observed at your facility. It is your responsibility to assure adherence with all requirements of the regulations.

Based on the inspectional findings, we are classifying your facility as "Provisional" for interstate carrier use for a period of thirty (30) days. A "Provisional" classification means that the facility may continue to operate; however, significant correction of violations must be made by the expiration date. On or about that date, a re-inspection of this facility will be conducted to assure that corrections meet FDA requirements. If significant corrections are not made by the time of the next inspection, this facility will be reclassified as "Not Approved" for carrier use. Assignment of "Not Approved" status prohibits the use of your water and waste disposal services for interstate conveyances until the violations have been corrected and the facility has been reinspected by FDA.

You should notify this office in writing, within fifteen (15) working days of the receipt of this letter, of the specific steps that you have taken to prevent a recurrence of the cited deficiencies. Your response should include a discussion of any delays you foresee in achieving correction, and a deadline by which correction can be expected. Your response should be directed to:

Warren E. Savary, Compliance Officer
U.S. Food and Drug Administration
1431 Harbor Bay Parkway
Alameda, CA 94502

You may wish to FAX your response to Mr. Savary at (510) 337-6707.

Sincerely,

/s/

Dennis K. Linsley

District Director

San Francisco District