Brigham and Women’s Hospital Inc.

Warning LetterClosed

Sunil Eppen, MD Interim President and Chief Medical Officer Brigham and Women’s Hospital Inc. 15 Francis Street Boston , MA 02115 United States seppen@partners.orgFEI 3012030543Issued Apr 11, 2022Office of Pharmaceutical Quality Operations Division I

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3012030543.

Violations2

Issue DateApr 11, 2022

Product TypeDrugs

StatusClosed

Closeout LetterMay 31, 2023

Letter Details

Firm: Brigham and Women’s Hospital Inc.
Location: Sunil Eppen, MD Interim President and Chief Medical Officer Brigham and Women’s Hospital Inc. 15 Francis Street Boston , MA 02115 United States seppen@partners.org
FEI Number: 3012030543
Country: United States
Issue Date: April 11, 2022
Issuing Office: Office of Pharmaceutical Quality Operations Division I
Product Type: Drugs
Status: Closed
Closeout Letter: May 31, 2023

Summary

Brigham and Women's Hospital Inc. was cited for significant Current Good Manufacturing Practice (CGMP) violations in the production of Positron Emission Tomography (PET) drugs, making those products adulterated. The facility failed to maintain adequate controls to prevent contamination, with particular deficiencies in equipment cleanliness, suitability for aseptic processing, and facility design—including uncontrolled water infiltrations in the Technical Corridor from July through October 2020. The violations were identified during an FDA inspection conducted from August 5 to September 16, 2021, and rendered the company's PET drug products non-compliant with 21 CFR Part 212 requirements for parenteral administration.

Brigham and Women’s Hospital Inc. FDA Warning Letter, April 11, 2022