Radcliff/Economy Marine Service, Inc. 21-Feb-02

DEPARTMENT of Health and Human Services

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-23

FEDERAL EXPRESS

OVERNIGHT DELIVERY

Mr. Barton G. Radcliff, President

Radcliff Economy Marine Service, Inc.

5 South Water Street

Mobile, Alabama 36652

Dear Mr. Radcliff:

During an inspection of your vessel watering point facility, located at 5 South Water Street, Mobile, Alabama, on January 30, 2002, our inspector observed violations of the Interstate Conveyance Sanitation Regulations Title 21, Code of Federal Regulation, 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. Sumner G. Adams, Vice President. The following deficiencies were observed during the inspection:

• Your potable water hydrant is not in a manner that prevents contamination of the water. For example, your potable water outlet is not equipped with a backflow prevention device, e.g. check valve, and capping device to cover the outlet during periods of non-use; and,

• Your potable water hydrant was not identified for its intended use.

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 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 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 t is inspection Mr. Adams 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 he reason for the delay and a deadline by which you will correct any remaining deficiencies.

We are notifying the users of your watering point of the "Provisional" classification of this facility by separate letter.

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

Sincerely,

Carl E. Draper

District Director

New Orleans District