Brigham and Women’s Hospital Inc.

CLOSEOUT LETTER Brigham and Women’s Hospital Inc. MARCS-CMS 623476 — May 24, 2023 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Electronic Mail - Delivery and Read Receipt Requested Product: Drugs Recipient: Recipient Name Dr. Robert Higgins Recipient Title President and CEO Brigham and Women’s Hospital Inc. 15 Francis Street Boston , MA 02115-6110 United States rhiggins4@bwh.harvard.edu Issuing Office: Office of Pharmaceutical Quality Operations Division I United States Dear Dr. Higgins: 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 # 623476], dated April 11, 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 Operations, Division I CC: Dr. Jonathan Barlow Director Nuclear Pharmacy Services and BICOR Brigham and Women’s Hospital Inc. 75 Francis Street Boston, MA.02115-6110 Email: jkbarlow@bwh.harvard.edu Content current as of: 05/31/2023 Regulated Product(s) Drugs