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  5. Brigham and Women’s Hospital Inc. - 623476 - 05/24/2023
  1. Warning Letters

CLOSEOUT LETTER

Brigham and Women’s Hospital Inc. MARCS-CMS 623476 —

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

 
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