483
Brigham and Women's HospitalBrigham and Women's Hospital – FDA 483, Jun 22, 2026
Record Details
An FDA inspection of Brigham and Women's Hospital, Inc., The, a Positron Emission Tomography Drug Manufacturer in Boston, MA, revealed an issue with facility adequacy. Specifically, an insect was found in an ISO-7 classified cleanroom, raising concerns about potential contamination of equipment or product. This indicates a moderate severity issue related to environmental control in a sterile manufacturing environment.
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ID · 303bf654-bf79-4445-8d7d-16d1ad89239b
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