Konrad Rejdak, MD, PhD

CLOSEOUT LETTER Konrad Rejdak, MD, PhD MARCS-CMS 671405 — May 01, 2025 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Drugs Recipient: Recipient Name Konrad Rejdak, M.D. Konrad Rejdak, MD, PhD Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie, ul. Jaczewskiego 8, 20-090 Lublin Poland Rejdakk@gmail.com Issuing Office: Center for Biologics Evaluation and Research (CBER) United States Secondary Issuing Offices United States Dear Dr. Rejdak: The United States Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CBER 24-671405 dated May 29, 2024. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections. The FDA conducted this assessment under the Bioresearch Monitoring (BIMO) Program that includes inspections designed to review the conduct of research involving investigational products. This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or other applicable law. The FDA has several references available at www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm that offer information on human subject protection and the conduct of clinical research. If you have any questions, you may contact CDR Peter Lenahan by email at Peter.Lenahan@FDA.HHS.GOV. Sincerely, /S/ Melissa J. Mendoza, JD Director, Office of Compliance and Biologics Quality Center for Biologics Evaluation and Research cc: Baxalta US Inc. 300 Shire Way Lexington, MA 02421 Jennifer Adams, Branch Chief FDA OII BIMO Foreign Investigation Branch Content current as of: 11/10/2025 Regulated Product(s) Drugs