Reference #: BLA 125350/1472 Product: Biologics Recipient:

Recipient Name

Pamela Lee

Recipient Title

Head, Global Advertising & Promotion

CSL Behring

1060 First Avenue
King of Prussia, PA 19406
United States

Issuing Office: Center for Biologics Evaluation and Research (CBER)

United States

Secondary Issuing Offices

Dear Ms. Lee:

The Food and Drug Administration has completed evaluation of your corrective actions in response to our Warning Letter dated September 09, 2025. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter.

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 with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during subsequent surveillance or through other means.

Sincerely,
/S/
Kristine Khuc, Pharm.D.
Branch Chief
Advertising and Promotional Labeling Branch
Division of Case Management
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research