Classic Charter, Inc. 06-Sep-01

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration

San Francisco District

1431 Harbor Bay Parkway

Alameda, CA 94502-7070

Telephone: 510-337-6700

VIA FEDERAL EXPRESS

Our Reference: 2954866

September 6,2001

WARNING LETTER

Chris S. Riddington, President

Classic Charter, Inc.

30201 Road 88

Visalia, California 93292

Dear Mr. Riddington:

On August 7,2001, the U.S. Food and Drug Administration (FDA) conducted an

inspection of your facility located at 30201 Road 88, Visalia, California, which provides

watering point and waste service for Classic Charter busses. Your operations at this site

are in violation of the federal regulations for control of communicable diseases which are

established in Title 21, Code of Federal Regulations, Part 1240 (21 CFR 1240), and for

interstate conveyance service area sanitation which are established in Part 1250 (21 CFR

1250), under authority granted in Section361 of the Public Health Service Act.

The lack of adequate sanitary practices and conditions was demonstrated by the following

deficiencies:

1. There is no back flow prevention device attached to the potable water line that is

connected to a hose in the bus lavatory service area. A Y-connector was observed

attached to the potable water line. one hose attached to the Y-connector is used for.

bus waste dumping and the other hose attached to the Y-connector is used for

providing potable water to the busses. The ends of the hoses are stored in direct

contact with the ground.

2. Brown standing water was observed around the bus waste dumpsite and the potable

water line. Grass was observed growing around the bus waste dumpsite, and empty

chemical bottles and plastic containers were observed stored on the grass.

3. There is no soap available at the employee hand-washing sink. Towels used for

hand-drying are greasy and dirty. There is no sign posted instructing employees to

use the hand-washing facilities.

4. The potable water outlets for the busses are uncapped.

The insanitary conditions and practices 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 and practices 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 you after the inspection. Form FDA 483, Inspectional

Observations, and Form FDA 2589, Inspection Summary-Bus Service Area Sanitation

were issued to you, 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. P1ease 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,

Dennis K. Linsley

District Director

San Francisco District