483
Covance Clinical Research Unit, Inc.FDA 483 - Covance Clinical Research Unit, Inc. - June 07, 2019
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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