FDA 483 - Natalia S. Hegedosh, M.D. - April 21, 2022

The 483 report for Natalia Hegedosh, M.D. details significant deficiencies in the conduct of a clinical investigation. Observations include the randomization and administration of investigational product to subjects who did not meet inclusion/exclusion criteria or were in the incorrect treatment stratum. Additionally, the firm failed to maintain adequate case histories, with missing or inaccurate documentation regarding subject therapy, source documents, and assessments during follow-up visits.