# FDA 483 - Glens Falls Hospital IRB - August 14, 2023

Source: https://www.keypedia.com/records/483/glens-falls-hospital-irb/2dd2f91b-6e6a-46d9-9852-447b6950922b

> FDA 483 for Glens Falls Hospital IRB on August 14, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Glens Falls Hospital IRB
- Inspection Date: 2023-08-14
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Glens Falls Hospital IRB in Glens Falls, NY, was inspected by the FDA from August 7-14, 2023. The inspection revealed that the IRB failed to conduct continuing review of research at least once per year, leading to significant lapses in approval for a Humanitarian Use Device study. Additionally, the IRB did not notify clinical investigators of these lapses.

## Related Officers

- [investigator](https://www.keypedia.com/people/benton-m-ketron/34d763d8-4374-4c8b-8dd6-dce1a83dcd01)

Company: https://www.keypedia.com/companies/glens-falls-hospital-irb/a1ef5dc2-eab3-4f78-a908-15b09ea89cea

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