Dr. Amira Al-Uzri, M.D. – FDA 483, Jun 18, 2026

Doernbecher Childrens Hospital, Oregon Health and Science University, was inspected regarding a clinical investigation and received a Form 483. The inspection revealed significant deficiencies in maintaining accurate and contemporaneous case histories, including issues with informed consent documentation and inconsistent recordkeeping for subject data. Additionally, the firm failed to retain required investigational records and did not consistently obtain permission from both parents for pediatric subjects as required.