# FDA 483 - Institutional Review Board of Franciscan Health Lafayette - October 18, 2017

Source: https://www.globalkeysolutions.net/records/483/institutional-review-board-of-franciscan-health-lafayette/71d17987-4b4c-4e95-8aed-c893873d4ae1

> FDA 483 for Institutional Review Board of Franciscan Health Lafayette on October 18, 2017. Product: other. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Institutional Review Board of Franciscan Health Lafayette
- Inspection Date: 2017-10-18
- Product Type: other
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: The FDA inspected the Institutional Review Board of Franciscan Health Lafayette and identified a significant deficiency. The IRB failed to conduct continuing review of research studies and informed consents at least annually. This lapse in oversight was evidenced by multiple protocols experiencing substantial delays in their required review cycles.

## Related Officers

- [U.S. Food and Drug Administration](https://www.globalkeysolutions.net/people/myra-k-casey/a2fae714-2ba3-4c60-9f54-990fc7b169c9)

Company: https://www.globalkeysolutions.net/companies/institutional-review-board-of-franciscan-health-lafayette/7160d6d0-9165-4bd0-aa2f-40659d40126a

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