483
Henry Okonkwo, P.A.FDA 483 - Henry Okonkwo, P.A. - July 01, 2018
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Record Details
An FDA inspection of Henry Okonkwo, P.A. in Los Angeles, CA, a clinical investigator, revealed a significant issue with incomplete subject case histories. The firm failed to maintain source documentation for specialist assessments, reportedly destroying these documents after e-CRF entry as instructed by a monitor. This practice resulted in e-CRF entries with audit trail timestamps indicating data entry occurred days after subject visits, rather than direct entry.
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