Inspections, Compliance, Enforcement, and Criminal Investigations
John W. Stone Oil Distributors, L.L.C. 28-Sep-01
DEPARTMENT OF HEALTH AND HUMAN SERVICE
Food and Drug Administration
New Orleans District
6600 Plaza Drive, Suite 400
New Orleans, LA 70127-2601
September 28, 2001
WARNING LETTER NO. 2001-NOL-57
Mr. John W. Stone, Jr., President
John W. Stone Oil Distributors, L.L.C.
87 First Street
Gretna, Louisiana 70053
Dear Mr. Stone:
During an inspection of your vessel watering point facility, located at 150 20th Street, Port Fourchon, Louisiana on September 19, 2001, our investigator observed violations of the Interstate Conveyance Sanitation Regulations (Title 21, Code of Federal Regulations, Parts 1240 and 1250).
During the inspection, the findings were discussed with Mr. Karl M. Boffanie, Operations Manager. 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 [redacted] Dock Foreman. The following deficiencies were observed during the inspection:
. Potable water hydrant outlet numbers 4 and 6 did not have backflow protection devices;
. Potable water hoses at hydrant numbers 2,3,4, and 5 were not capped nor properly stored and dragged on the ground; and,
. Potable water hydrant outlet number 1 was not capped when not in 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 reinspection of this facility will be conducted to assure corrections meet FDA 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 your operations meet all requirements of the U.S. Public Health Service Act and its implementing regulations.
We are aware that during and at the close of the inspection Mr. Boffmie and [redacted] made verbal commitments 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,
Richard D. Debo
Acting District Director
New Orleans District