# FDA 483 - Candler Hospital Inc Irb - August 07, 2019

Source: https://www.keypedia.com/records/483/candler-hospital-inc-irb/b5561637-30fe-47bd-a016-5ed737038573

> FDA 483 for Candler Hospital Inc Irb on August 07, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Candler Hospital Inc Irb
- Inspection Date: 2019-08-07
- Product Type: other
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Candler Hospital Inc Irb, an Institutional Review Board, revealed two significant observations. The IRB failed to follow its written procedures for conducting continuing review of research protocols, leading to instances of unapproved or undocumented reviews. Additionally, the IRB did not promptly notify investigators in writing when research activities were disapproved or required modifications.

## Related Officers

- [Deborah A. Greco](https://www.keypedia.com/people/deborah-a-greco/38e393b5-55c4-461c-a0b0-4937e0cbec37)
- [Brandy D. Brown](https://www.keypedia.com/people/brandy-d-brown/667c6b9a-6ab9-42d4-b364-a96207bca072)

Company: https://www.keypedia.com/companies/candler-hospital-inc-irb/4134c613-f405-4b36-b676-1a7c2c922f37

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7