# FDA 483 - Bruce Henry Properties, LLC DBA Bonadent - March 25, 2022

Source: https://www.keypedia.com/records/483/bruce-henry-properties-llc-dba-bonadent/002bea64-723a-4630-8c88-71a2bc5efca2

> FDA 483 for Bruce Henry Properties, LLC DBA Bonadent on March 25, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bruce Henry Properties, LLC DBA Bonadent
- Inspection Date: 2022-03-25
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Bruce Henry Properties, LLC DBA Bonadent, a contract manufacturer in Seneca Falls, NY, was inspected by the FDA. The inspection revealed two observations concerning inadequate procedures for product identification and insufficient establishment of supplier requirements. These issues indicate a need for improved quality system controls.

## Related Officers

- [investigator](https://www.keypedia.com/people/wendy-m-stone/715b04f5-3949-4ca6-9bda-26ff611e9354)

Company: https://www.keypedia.com/companies/bruce-henry-properties-llc-dba-bonadent/645337e2-2e33-47c7-aa7a-9f336e1ec0de

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961