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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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San Francisco Terminal Equipment Co. 10-May-02

HHS symbolDEPARTMENT 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: FEI3003615694

Jeffrey D. Seid, Executive Director
San Francisco Terminal Equipment Co. (LLC)
San Francisco International Airport
5th Floor NITB
San Francisco, CA 94128

Dear Mr. Seid:

On March 19, 2002, the U.S. Food and Drug Administration (FDA) inspected your facility, San Francisco Terminal Equipment, located at San Francisco International Airport, San Francisco, CA, which provides water to a number of airlines at San Francisco International Airport. The observations made during this inspection are in violation of the Public Health Service Act as promulgated in the Interstate Conveyance Sanitation regulations set forth at Title 21, Code of Federal Regulations, Part 1250 (21 CFR 1250). A List of Inspectional Observations (FDA Form 483; copy enclosed) was issued to you and discussed with you at the conclusion of the inspection.

The following violations were observed during the inspection:

The aircraft potable water cabinets, where potable water hoses are stored, are not properly protected from environmental contamination.

The potable water hose ends are not capped at gates A2, A6, A7, A9, A10, A11a, A11b, G91, G92, G94, G95, G96,G97, G98, G99A, G99B, G100, and G101.

The uncapped hose ends were in direct contact with brown standing water at gates A7 and G94. At gate G96, the uncapped hose end was in direct contact with garbage debris.

At gate A% the uncapped hose end was in direct contact with the bottom of the cabinet, and at gate G99A, it was in direct contact with sand in the bottom of the cabinet. Sand was also observed in the bottom of the potable water cabinets at gates G91 and G95.

Garbage and debris, including empty soda cans, used gloves, paper, and other items, were present in a number of the cabinets, and built-up grease and dirt were observed on the many cabinet doors.

The above list of inspectional observations is not intended to include all of the conditions observed at your facility. You should take prompt action to correct all deficiencies.

The deficiencies found at your 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 for 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, the 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 re-inspected by FDA.

You should notify this office, within fifteen (15) working days of the receipt of this letter, of the specific steps that you have taken to correct the violations and prevent a recurrence of the cited deficiencies. If you cannot complete all corrections before you respond, please explain the reason for the-delay and provide a deadline by which you will correct any remaining violations.

Your response should be directed to:

Warren E. Savary, Compliance Officer

U.S. Food and Drug Administration

143 1 Harbor Bay Parkway

Alameda, CA 94502

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

Sincerely,

Dennis K. Linsley

District Director

San Francisco District