Brigham and Women's gets FDA warning letter after PET operation violations
A drug manufacturing facility at one of Boston’s top hospitals has received a warning letter from the FDA after its manufacturing practices for positron emission tomography drugs were not found to be up to regulatory code.
The FDA addressed Brigham and Women’s Hospital in a letter dated April 11. The letter is addressed to Sunil Eappen, the interim president and CMO at the hospital.
Facilities were not adequately prepared to prevent the contamination that could lead to side effects in the products, the letter said. The hospital also did not ensure that the equipment is suitable for aseptic operations. “Water infiltrations” that occurred between July and October 2020 were in close proximity to equipment used in the PET aseptic production operation, including hot cells, biological safety cabinet, and the laminar flow hood. An overhead water pipe was actively leaking onto the floor in the same room in which raw materials were stored too, and there were fungal species found in the ISO 5 classified cells.
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