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WARNING LETTER
•Town of Bucksport•July 28, 2008

Town of Bucksport – FDA Warning Letter, Jul 28, 2008

Record Details

On October 7, 2008, the FDA issued a Warning Letter to the Town of Bucksport, Maine, classifying its vessel watering point at 94 Main Street as "Provisional." This classification resulted from an FDA inspection on June 11 and July 28, 2008, which found significant deviations from the Interstate Conveyance Sanitation regulations (21 CFR Part 1250) under the Public Health Service Act.

The inspection revealed two primary violations: 1. Failure to prevent backflow: The facility's potable watering points lacked backflow prevention devices, violating 21 CFR 1250.82(e). 2. Failure to prevent water contamination: A garden hose, used for potable water delivery to vessels, was observed lying unprotected on the pier, violating 21 CFR 1250.67(a).

These findings were documented on a Form 483 issued to David L. Milan. A "Provisional" classification allows conveyances to continue obtaining water, but significant corrections are required. The FDA will re-inspect the facility, and failure to make corrections could lead to a "Non-Approved" classification, prohibiting conveyances from using the watering point. The Town of Bucksport must respond in writing within fifteen days, detailing corrective measures or explaining any delays and expected completion dates.

Company
Town of Bucksport
Inspection date
July 28, 2008
Product type
Biologics
Office
New England District Office
Person
  • Domeric J. Veneziano (Veneziano Consulting LLC)
View Company Profile

ID · 9d7e4bee-ccbf-4192-98c1-bd7bedc0a3d8

Violation Codes4
21 CFR 125021 CFR 1250.82(e)21 CFR 1250.67(a)21 CFR 1240.80

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