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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Waterways Marine of Greenville Inc 23-Apr-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

April 23, 2002
WARNING LETTER NO. 2002-NOL-28
FEDERAL EXPRESS
OVERNIGHT DELIVERY

Mr. Peyton M. B. Self III, President
Waterways Marine of Greenville, Inc
235 East Main Street
Marks, Mississippi 38646

Dear Mr. Self:

The U.S. Food and Drug Administration inspected your vessel watering point facility, Waterways Marine of Greenville, Inc., located at 100 Warfield Point Road, Greenville, Mississippi, on March 28, 2002. The observations made during the inspection are in violation of the Public Health Service Act and its implementing regulations for the Control of Communicable Diseases and Interstate Conveyance Sanitation found at Title 21, Code of Federal Regulations, Parts 1240 and 1250.

At the conclusion of the inspection, a list of Inspectional Observations, FDA Form 483 (copy enclosed) and an Inspection Summary-Vessel Watering Point Sanitation, Form FDA 2521 (copy enclosed) were issued to and discussed with Mr. Robert S. Luttrell, Executive Vice President. The following violations were observed during the inspection:

  • No back-flow protection device was installed on the potable water hydrant on the apex barge;
  • A potable water hydrant was used for non-potable purposes;
  • Potable and non-potable hydrants on the same pier were not properly identified;
  • The potable water hydrant on the apex barge had no cap and keeper chain attached;
  • Two of three potable water hoses were not capped properly nor stored; and,
  • Your potable water appurtenances were not capped nor stored properly.

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. It is your responsibility to assure adherence with all requirements of the Public Health Service Act and its associated regulations.

Based on the inspectional observations, we are classifying your facility as PROVISIONAL for interstate carrier use for a period of 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 corrections meet FDA requirements. If significant corrections have not been made at the time of the next inspection, your facility may be placed on a "Not Approved" status. By separate letter, FDA is notifying your users of the Provisional classification of your watering point facility.

We are aware that, at the close of the inspection, Mr. Luttrell verbally committed to correct the violations. You should advise this office in writing, within 15 days from your receipt of this letter, of the specific steps you have taken to correct the violations and to assure that such violations will not recur. 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.

Direct your response 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