FDA 483 - Natalia S. Hegedosh, M.D. - April 21, 2022
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.
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.
ID · eabe98ab-19f2-461b-8292-01cf3e476ade