Mother Frances Hospital IRBApril 2, 2013

FDA 483 - Mother Frances Hospital IRB - April 02, 2013

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Record Details

An FDA inspection of Mother Frances Hospital IRB in Tyler, TX, revealed significant deviations from its written procedures for human research protection. The firm failed to properly conduct continuing reviews, including issues with unqualified staff reviewing clinical events and incomplete documentation. Additionally, the IRB did not consistently follow its procedures for reporting actions to investigators and maintaining complete correspondence records.

Company: Mother Frances Hospital IRB
Inspection Date: April 2, 2013
Product Type: Other
Office: Dallas District Office
Person: Elisa M. Fleming (Investigator)

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ID · 69469d52-c983-49b6-ab65-9b89cc5ff4a1