FDA 483 - Deyan Anakievski - February 21, 2025

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.