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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.