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.

“Your investigation states that the water infiltrations were due to multiple failures associated with the mechanical suite above your manufacturing area and with the roof penetrations leading into the plenum spaces above your cleanroom areas,” the FDA said. “Notably, the EM data indicates that the water infiltration problem preceded the date of detection and manifested as a loss of environmental control in your aseptic production facility. The failure to appropriately design and maintain the facility led to a lack of control and subjected drug products to the risk of contamination.”

Several fungal organisms were also found in the air quality of critical areas of manufacturing that should not be contaminated, the letter said. Fludeoxyglucose for injection, which is used to help diagnose cancer, heart disease and epilepsy, and ammonia for injection, used for PET imaging, were both produced in the area. The team at BWH also acknowledged that there was not enough contact time for sporicidal disinfectant used in the area of biological safety cabinets and hot cells.

The FDA deemed BWH’s response from a previous Form 483 inadequate because, while it indicated that it would continue PET drug manufacturing while making the necessary changes, it didn’t provide a sufficient plan for improvement.

“Furthermore, you did not explain what additional steps you would take to prevent contamination while you continue manufacturing during remediations,” the FDA said. “Your response also failed to sufficiently address your ISO 5 decontamination program to improve its robustness such as assessing the potential for increasing disinfection frequency, ensuring more comprehensive application of disinfectants to all surfaces in critical environments and surrounding environments, and other steps that would ensure more effective disinfection.”

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