Institutional Review Board of Franciscan Health LafayetteOctober 18, 2017

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

Record Details

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.

Company: Institutional Review Board of Franciscan Health Lafayette
Inspection Date: October 18, 2017
Product Type: Other
Office: Division of Pharmaceutical Quality Operations III
Person: Myra K. Casey (U.S. Food and Drug Administration)

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ID · 71d17987-4b4c-4e95-8aed-c893873d4ae1