483
Covance Clinical Research Unit, Inc.Covance Clinical Research Unit, Inc. – FDA 483, Jun 7, 2019
Record Details
An FDA inspection of Covance Clinical Research Unit, Inc. in Dallas, TX, revealed a significant issue with record retention. The firm failed to maintain individual blinding codes for a clinical trial for the required two-year period, destroying them prematurely. This indicates a serious lapse in regulatory compliance regarding document control for clinical investigations.
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ID · ed4f092c-473c-484d-8f53-c820699e49f3
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