Cangene BioPharma, LLC

CLOSEOUT LETTER Cangene BioPharma, LLC MARCS-CMS 630316 — October 04, 2023 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: ELECTRONIC DELIVERY/READ RECEIPT Product: Drugs Recipient: Recipient Name Mr. David Fidler Recipient Title Vice President, Manufacturing Operations, General Manager Cangene BioPharma, LLC 1111 S. Paca St. Baltimore , MD 21230 United States fidlerd@ebsi.com Issuing Office: Division of Pharmaceutical Quality Operations I United States Dear Mr. Fidler: The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter [CMS #630316], dated August 10, 2022. Based on our evaluation, it appears that you have adequately 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 a subsequent inspection or through other means. Respectfully, /S/ Lisa Harlan Program Division Director U.S. Food and Drug Administration Office of Pharmaceutical Quality Operations Division I Content current as of: 10/04/2023 Regulated Product(s) Drugs