# FDA 483 - Asen Georgiev Medzhidiev - December 16, 2022

Source: https://www.globalkeysolutions.net/records/483/asen-georgiev-medzhidiev/effabb85-88ca-48d0-b306-630baba69246

> FDA 483 for Asen Georgiev Medzhidiev on December 16, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Asen Georgiev Medzhidiev
- Inspection Date: 2022-12-16
- Product Type: drugs
- Office Name: Center for Veterinary Medicine
- Summary: An FDA inspection of Asen Georgiev Medzhidiev, M.D., a clinical investigator in Sofia, Bulgaria, revealed a significant deviation from the investigational plan for a COVID-19 study. Site personnel failed to ensure participants created confidential device PIN codes, instead instructing them to use easily guessable birth years, compromising data integrity and participant privacy.

## Related Officers

- [Business Analyst/Provider Enrollment Specialist](https://www.globalkeysolutions.net/people/lakecha-n-lewis/39b6305d-2a9f-448b-9a14-e412b43c8522)

Company: https://www.globalkeysolutions.net/companies/asen-georgiev-medzhidiev/24fc5b01-7efa-4a98-a3e7-320c3c30c5b4

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