# FDA WARNING_LETTER - Town of Bucksport - July 28, 2008

Source: https://www.keypedia.com/records/warning_letter/town-of-bucksport/9d7e4bee-ccbf-4192-98c1-bd7bedc0a3d8

> FDA WARNING_LETTER for Town of Bucksport on July 28, 2008. Product: Biologics. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Town of Bucksport
- Inspection Date: 2008-07-28
- Product Type: Biologics
- Office Name: New England District Office
- Summary: 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.

## Related Officers

- [Veneziano Consulting LLC](https://www.keypedia.com/people/domeric-j-veneziano/02094e79-9780-4978-bb39-37c81de30b65)

Company: https://www.keypedia.com/companies/town-of-bucksport/2c83fec4-79fb-48dc-9ee8-3d872db482fc

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144