FDA 483 - Laura A. Nussbaum, M.D. - December 06, 2024
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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.
ID · 11f56ff0-b74a-4012-a553-4fda5f60a6c3