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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Transtar Corporation 21-Feb-02

DEPARTMENT OF HEALTH AND HUMAN SERVICE

Food and Drug Administration

New Orleans District

Southeast Region

6600 Plaza Drive, Suite 400

New Orleans, Louisiana 70127

Telephone: 504-253-4519

Facsimile: 504-253-4520

February 21, 2002

WARNING LETTER NO. 2002-NOL-22

FEDERAL EXPRESS

OVERNIGHT DELIVERY

Mr. Thomas W. Sterling, President

Transtar Corporation

135 Jamison Lane

Monroeville, Pennsylvania 15146

Dear Mr. Sterling:

During an inspection of your vessel watering point facility, Warrior and Gulf Navigation

Company, located at 50 Viaduct Road, Chickasaw, Alabama, on January 3 1,2002, our inspector observed violations of the Interstate Conveyance Sanitation Regulations (Title 21, Code of Federal Regulations, Parts 1240 and 1250).

At the conclusion of the inspection, a list of Inspectional Observations, Form FDA 483 (copy enclosed), and an Inspection Summary-Vessel Watering Point Sanitation, Form FDA 2521 (copy enclosed), were issued to and discussed with Mr. Earl F. Horton, Vessel Maintenance Supervisor. The following deficiencies were observed during the inspection:

A potable water hydrant and attached hose on your fuel dock were used for non-potable

purposes; and,

Potable and non-potable water hydrants and hoses on the same pier were not identified for their intended uses.

As a result of the above observations, we are classifying your watering point as "Provisional" for interstate carrier use for a period of thirty (30) days. A Provisional classification means the facility may continue to operate; however, significant correction of violations must be made within thirty days. On or about that date, a re-inspection of this facility will be conducted to assure corrections meet FDA? s requirements. If significant corrections have not been made at that time, a "Not Approved" classification will be justified. A classification of "Not Approved" means that interstate carrier companies are prohibited from using the facility.

You should take prompt action to correct all deficiencies. This letter is not meant to be an all-inclusive list of deficiencies that may exist at your vessel watering point. It is your

responsibility, as a servicer of interstate conveyances, to ensure all locations of your operations meet all requirements of the U.S. Public Health Service Act and its associated regulations.

We are aware that at the close of this inspection Mr. Horton made a verbal commitment to correct the violations. However, you should notify this office in writing, within 15 days from your receipt of this letter, of the specific steps you have taken to correct the deficiencies and to assure that such violations will not recur. If you cannot complete all corrections before you respond, we expect you will explain the reason for the delay and a deadline by which you will correct any remaining deficiencies.

Your response should be addressed to the U.S. Food and Drug Administration, Attention: Ms. Nicole F. Hardin, Compliance Officer, at the above address. If you have questions regarding any issue in this letter, you may direct them to Ms. Hardin at the above address or at 504-253-4519.

Sincerely,

Carl E. Draper

District Director

New Orleans District