FDA investigators visited the facility between Aug. 5 and Sept. 16, 2021. Inspectors found the facility was not adequately designed to prevent contamination of the manufacturing equipment or PET drugs in production, the FDA said in an April 11 warning letter to Brigham and Women’s.
The agency cited a series of water leaks that occurred in the manufacturing facility near equipment used to produce the PET drugs between July and October 2020. The FDA also noted the facility’s environmental monitoring system detected fungal organisms in air samples taken from critical areas of the facility.
The FDA requested Brigham and Women’s share how it’s working to prevent contamination as it updates manufacturing processes.
In a May 16 statement to Becker’s, Brigham and Women’s said it voluntarily paused manufacturing of radiopharmaceuticals and is working with two outside experts to address the FDA’s concerns.
The hospital has already taken several measures to remedy issues identified in the inspection, including a full facility assessment, significant investments in facility infrastructure improvements and enhancements to its quality assurance process. The hospital said it plans to respond to the FDA’s letter detailing these efforts in the coming days.
“It is important to note that we have not had any patient-safety events related to the use of our radiopharmaceuticals,” Brigham and Women’s said. “To support care for our patients, we have transitioned to alternative radiopharmaceutical options.”
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