# FDA 483 - SCL Health IRB - November 07, 2019

Source: https://www.keypedia.com/records/483/scl-health-irb/06dea7c7-a786-4a15-b877-a4c2acdbf98c

> FDA 483 for SCL Health IRB on November 07, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SCL Health IRB
- Inspection Date: 2019-11-07
- Product Type: other
- Office Name: Denver District Office
- Summary: An FDA inspection of SCL Health IRB in Broomfield, CO, identified significant deficiencies in their Institutional Review Board (IRB) record-keeping practices. The firm failed to maintain detailed and accurate IRB meeting minutes, specifically regarding member attendance and voting records. Additionally, the inspection revealed that the list of IRB members was not properly maintained or updated, lacking essential identifying information.

## Related Officers

- [Jonathan R. Campos](https://www.keypedia.com/people/jonathan-r-campos/f4c6aba7-d0fe-43d2-95ae-5eb86a6659a4)

Company: https://www.keypedia.com/companies/scl-health-irb/90676b8d-7ee7-4d5f-8536-33538d9b2065

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face