# FDA 483 - ACMH Hospital IRB - November 08, 2023

Source: https://www.globalkeysolutions.net/records/483/acmh-hospital-irb/8d12eace-9dc5-4640-99d5-b7a37dd63926

> FDA 483 for ACMH Hospital IRB on November 08, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ACMH Hospital IRB
- Inspection Date: 2023-11-08
- Product Type: other
- Office Name: Philadelphia District Office
- Summary: ACMH Hospital IRB in Kittanning, PA, was inspected and received a Form 483 with ten observations. The observations primarily concern the lack of written procedures for various critical IRB functions, including initial and continuing review, reporting changes, and handling noncompliance. Additionally, the IRB failed to conduct reviews at convened meetings and maintain adequate meeting minutes.

## Related Officers

- [Cynthia L. Rakestraw](https://www.globalkeysolutions.net/people/cynthia-l-rakestraw/ca138abf-e5d4-43ca-b9d2-79ea6294a8c8)

Company: https://www.globalkeysolutions.net/companies/acmh-hospital-irb/b69bbf4d-19a1-4f34-9a50-55c6a4add225

Office: https://www.globalkeysolutions.net/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8