483
Henry Okonkwo, P.A.Henry Okonkwo, P.A. – FDA 483, Jul 1, 2018
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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ID · 9b4b99b0-0fb5-42f4-acf0-6cb67b31bc8e
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