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

Source: https://www.keypedia.com/records/483/natalia-s-hegedosh-md/eabe98ab-19f2-461b-8292-01cf3e476ade

> FDA 483 for Natalia S. Hegedosh, M.D. on April 21, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Natalia S. Hegedosh, M.D.
- Inspection Date: 2022-04-21
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: 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.

## Related Officers

- [investigator](https://www.keypedia.com/people/matthew-f-duff/7efbc61c-5f7a-4d2c-86d9-500291ee6789)
- [Richard A. Lyght](https://www.keypedia.com/people/richard-a-lyght/8d60b5c0-4acd-4abc-979a-fb4b3e82964d)

Company: https://www.keypedia.com/companies/natalia-s-hegedosh-md/26a31635-ba69-4992-80eb-1106fe6964fe

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6