FDA 483 - Laura A. Nussbaum, M.D. - December 06, 2024

The FDA inspected Spitalul Clinic De Urgenta Pentru Copii Luis Turcanu Timisoara, Sectia Clinica, a clinical investigator site in Timisoara, Romania, from December 2-6, 2024. The inspection revealed significant failures to conduct a clinical trial in accordance with Good Clinical Practices and the investigational plan. These deficiencies included issues with subject screening, assessment administration, adverse event documentation, consent recordkeeping, and concomitant medication evaluation.