Day

July 19, 2005
19
Jul

Uroplasty Inc.

July 19, 2005
Recipient: Uroplasty Inc.Product: Investigational devices Date: 7/19/05 The inspectional report notes that review of subject records across five (5) investigational sites revealed that study procedures were initiated on 30 subjects prior to obtaining the informed consent of these individuals as required by the regulations at 21 CFR Part 50. The inspectional report further notes that...
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