FDA 483 - Dwayne Logan, M.D. - August 01, 2023
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
An FDA inspection of Dwayne K. Logan, M.D., a clinical investigator in Huntington Beach, CA, revealed significant deficiencies in record-keeping and adherence to investigational plans. The inspection found that original source records were missing for multiple subjects and visits, and serious adverse events were not reported to the sponsor or recorded in EDC in a timely manner. Additionally, investigations were not conducted in accordance with the signed statement of investigator and investigational plan.
ID · acb14bca-6ab1-42fc-b0d5-6cb647032c91