# FDA 483 - Deyan Anakievski - February 21, 2025

Source: https://www.keypedia.com/records/483/deyan-anakievski/5061ea3f-ad6d-473d-8bbe-46e640d63190

> FDA 483 for Deyan Anakievski on February 21, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Deyan Anakievski
- Inspection Date: 2025-02-21
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Deyan Anakievski, a clinical investigator in Burgas, Bulgaria, was cited for failing to maintain adequate case histories during an inspection from February 17-21, 2025. The inspection revealed issues with the preparation and administration records for investigational product mitomycin (UGN-102) and unauthorized revisions to source documents without proper justification. These deficiencies indicate a lack of control over critical study data.

## Related Officers

- [Anna M. Brannen](https://www.keypedia.com/people/anna-m-brannen/b8513ae4-9182-4024-94e4-dea1da4341be)

Company: https://www.keypedia.com/companies/deyan-anakievski/26f7cab2-d7b0-49d0-82ca-06b88d608d33

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8