# FDA 483 - Franciscan Health IRB - February 13, 2019

Source: https://www.keypedia.com/records/483/franciscan-health-irb/5b8d99c2-7919-437e-a3f2-c5bf1c4736bf

> FDA 483 for Franciscan Health IRB on February 13, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Franciscan Health IRB
- Inspection Date: 2019-02-13
- Product Type: other
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: The FDA inspected Franciscan Health IRB in Indianapolis, IN, and issued a Form 483 with two observations. The inspection revealed deficiencies in maintaining detailed IRB meeting minutes, specifically regarding attendance and vote counts for actions on FDA-regulated research. Additionally, the firm failed to maintain accurate and complete lists of IRB members, lacking earned degrees and failing to update member status promptly.

## Related Documents

- [483 - 2019-02-13](https://www.keypedia.com/records/483/franciscan-health-irb/d937abdb-c6d7-4cd9-9666-2ab3fed9526f)

## Related Officers

- [investigator](https://www.keypedia.com/people/corrine-m-carter/69e1be8c-1cd9-48d9-a08e-bf49060b94d6)

Company: https://www.keypedia.com/companies/franciscan-health-irb/af62a086-7965-42fe-86cb-990b15aa62f9

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0