483
Franciscan Health IRBFranciscan Health IRB – FDA 483, Feb 13, 2019
Record Details
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.
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ID · 5b8d99c2-7919-437e-a3f2-c5bf1c4736bf
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