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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Canadian American Transportation Systems 29-Jun-04

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

New York District
158-15 Liberty Avenue
3amaica, NY 11433


WARNING LETTER

CERTIFIED MAIL
REXURN RECEIPT REQUESTED

Howard Thomas
President
Canadian American Transportation Systems
1000 North River Street
Rochester, New York 146 12

June 29,2004

Ref: NYK-2004-21

Dear Mr. Thomas:

On June 8,2004, the Food and Drug Administration (FDA) conducted an inspection of your vessel watering point facility, located at 1000 North River Street, Rochester, New York. The observations made during the inspection revealed that your facility is in violation of Section 361 of the Public Health Service Act, the Interstate Conveyance Sanitation regulations (Title 21, Code of Federal Regulations, Part 1250 (2 1 CFR 2250) and the Control of Communicable Diseases regulations (21 CFR 1240).

At the conclusion of the inspection, Investigator Maselii presented the Inspectional Observations (Form FDA 483) and the Inspection Surnrnary/Vessel Watering Point Sanitation (Form FDA 2521) (copies enclosed) to Eric Mueller, Terminal Manager and discussed the findings with him. The deficiencies of concern were as follows:

1. Failure to provide adequate backflow prevention devices: Specifically, the backflow presenter device (RPZ) for the potable water service outlet was not accessible for inspection, and it appears that it is not installed directly in line at the point of service.

2. Failure to properly identify potable and non-potable hydrants on the same pier: Specifically, the potable water service outlet is on the same pier as the non-potable water service outlet and is not identified as “potable water” use only. The water service outlets are not of different colors in order to aid and to further distinguish their proper identification from each other.

3. Failure of water hoses being of acceptable material and condition: Specifically, a garden hose is in use and connected to the potable water service outlet.

The list of inspectional observations identified above is not intended to be an all-inclusive list of conditions observed at your facility. It is your responsibility to assure adherence with all applicable statutes and regulations enforced by FDA.

The deficiencies found at your servicing facility could contribute to the spread of communicable diseases, Based on the inspectional findings, we are classifying your facility as “Provisional” for interstate carrier use. A “Provisional” classification means that the facility may continue to operate; however, correction of deficiencies must be made by the expiration date. A reinspection of this facility will be conducted to assure that corrections meet FDA requirements. If significant corrections are not made by the time of the next inspection, this facility will be classified as “Not Approved” for carrier use. An assignment of “Not Approved” status prohibits the use of your watering point services by interstate conveyances until deficiencies have been corrected and the facility has been re-inspected by FDA.

You should notify this office in writing within 15 working days of the receipt of this letter. In your written response to FDA, you should outline the specific steps that you have taken to prevent a recurrence of the cited deficiencies. If corrective action cannot be completed within the 15 days, state the reason for the delay and the date by which the corrections will be completed. Also, please include copies of any available documentation that corrections have been made. Your response should be sent to the attention oE Bruce A. Goldwitz, Compliance Oflicer, Food and Drug Administration, 158-15 Liberty Avenue, Jamaica, NY 11433. If you have any questions, you can call Mr. Goldwitz at (7 18) 340-7000, ext. 5582.

Sincerely,
District Director