CSL Behring

CLOSEOUT LETTER CSL Behring MARCS-CMS 716297 — May 13, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters 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 United States 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 Content current as of: 05/21/2026 Regulated Product(s) Biologics