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

[email protected] Issuing Office: Center for Biologics Evaluation and Research (CBER)

United States

Secondary Issuing Offices

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 [email protected].

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