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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Greyhound Lines, Inc. 04-Sep-01

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service

Food and Drug Administration

San Francisco District
1431 Harbor Way Parkway
Alameda, CA 94502.7070
Telephone: 510-337-6700

WARNING LETTER

VIA FEDERAL EXPRESS
Our Reference: 2940161
September 4, 2001

Craig Lentzch, President/Chief Executive Officer
Greyhound Lines, Inc.
15110 North Dallas Parkway
Dallas, TX 75248

Dear Mr. Lentzch:

On Auhust 10, 2001, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 1033 Broadway Street, Fresno, California, which provides watering point and waste service for Greyhound busses. Your operations at this site are in violation of the federal regdations for control of communicable diseases which are established in Titie 21, Cock of Federal Regulations, Part 1240 (21 CFR 1240), and for interstate conveyance service area sanitation which are established in part 1250 (21CFR 1250), under authority granted in Section361 of the Public Health Service Act.

The lack of adequate sanitary conditions was demonstrated by the following deficiencies:

1.There is no back flow prevention device attached to the potable water line, which is used for cleaning the bus waste service area. A back flow prevention device is required because the potable water line is also comected to the potable water line of
the restaurant located next to the bus station. The end hose of the potable water line was observed stored directly on the ground while not in use.

2. Two of four lids, which cover the bus waste dumpsites, were observed to bear cracks and holes, approximately three inches in diameter.

The insanitary conditions may result in adulteration of the potable water within the meaning of Sections 402(a)(3) and 402(a)(4) of the Federal Food, Drug and Cosmetic Act (the Act). The insanitary conditions in the waste service area may cause the introduction,transmission, or spread of communicable diseases from one state into another state.

The findings were discussed with Mr. Vince Hemandez, Maintenance, after the inspection. Fonm FDA 483, Inspectional Obsenations, and Form FDA 2589, Inspection Summary-Bus Service Area Sanitation were issued to Mr. Hernandez, copies of which are attached for your ready reference.

Based on the findings of our inspection, your facility has been assessed a “Provisional” classification. A “Provisional” classification means that if the deficiencies are not corrected within thirty (30) working days from receipt of this notification, your facility
will be placed on “Not Approved” status. A ‘:Not Approved” status means that food and waste service will be prohibited from use by interstate conveyances at your facility.

Failure to take prompt corrective action may result in appropriate regulatory action, such as injunction without further notice. You should notify this office within fifteen (15) working days of receipt of this letter of the specific steps you have taken to correct the
violations, including an explanation of preventive measures taken to preclude recurrence of similar violations, If corrective action cannot be completed within fifteen ( 15) working days, cite the reason for the delay and the time by which the corrections will be
completed. Please direct your response to:

Randall P. Zielinski, CSO/ITS
U.S. Food and Drug Administration
1431 Harbor Bay Parkway
Alameda, CA 94502-7070

You may wish to FAX your response to Mr. Zielinski at (510) 337-6703.
Sincerely,
District Director
San Francisco District