# FDA 483 - Viktor Vass, MD - September 13, 2019

Source: https://www.keypedia.com/records/483/viktor-vass-md/22846917-3565-4ce0-9e7b-c026d0d62b61

> FDA 483 for Viktor Vass, MD on September 13, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Viktor Vass, MD
- Inspection Date: 2019-09-13
- Product Type: drugs
- Office Name: Center for Veterinary Medicine
- Summary: Synexus Hungary Health Care Service Ltd., a clinical investigator in Budapest, was cited for failing to conduct an investigation in accordance with its investigational plan. The inspection revealed deficiencies in the timely reporting of serious adverse events (SAEs) to the study sponsor, as required by the protocol. This indicates a lapse in adherence to established clinical trial procedures for patient safety reporting.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/camille-d-brown/419869d2-1810-40ea-8e8a-687de7013f6a)

Company: https://www.keypedia.com/companies/viktor-vass-md/de40573b-a3d6-4d2e-a440-146772100eb6

Office: https://www.keypedia.com/offices/center-for-veterinary-medicine/7e30a309-56e4-4e7a-8b8b-e07674bb07b4
