Brigham and Women’s Receives FDA Warning Letter After PET Operation Flaws

Brigham and Women’s Receives FDA Warning Letter After PET Operation Flaws

May 17th, 2022 // 1:22 pm @

A drug producer at one of the top hospitals in Boston received an FDA warning letter in April after the agency found its manufacturing practices for positron emission tomography drugs were not up to cGMP requirements.

FDA sent the letter to Brigham and Women’s Hospital on April 11. The letter was written to Sunil Eappen, president and CMO of the hospital.

First drug manufacturing facilities were not prepared to mitigate contamination that could cause side effects in the drugs, the warning letter said. The facility also did not make sure the equipment was sterilized and prepared for aseptic operations.

Water filtration that happened between July and October 2020 were too close to equipment used for the PET aseptic production operation. These included hot cells, biological safety cabinets, and the laminar flow hood. Also, an overhead water pipe was leaking onto the floor in the same room where raw materials were stored. There also were fungal species located in the ISO 5 classified cells.

The warning letter said the hospital’s investigation says that water infiltration were because of several failures related with the mechanical suite above the drug manufacturing area and roof penetrations that lead to the plenum spaces over the cleanroom areas. FDA added that EM data showed that the water infiltration issue happened before the date of detection and caused a loss of the environmental controls in the aseptic production area. This was caused by a failure to design and upkeep the facility and there was a lack of control. The result was subjecting drugs to a contamination risk.

Next, there were several fungi found in the air of vital areas for drug manufacturing and that shouldn’t happen. Also, fludeoxyglucose for injection, which is important for diagnosing heart disease, cancer, and epilepsy, as well as ammonia for infections, which is vital for PET imaging, were made in this area.

The workers at the hospital conceded there wasn’t enough time in contact with sporicidal disinfectant that was used in the room with biological safety cabinets, as well as the hot cells.

FDA said the hospital’s response from the last 483 wasn’t good enough because they said they would continue to do PET drug manufacture while they made the needed improvements. But they didn’t detail the plan that would lead to improvement.

The hospital also ddin’t explain the steps they’d take to avoid contamination as they continue drug manufacturing during corrective actions. Their response didn’t mention their ISO 5 decontamination program to enhance its effectiveness. Some examples could be checking for the possibility for boosting disinfection frequency, and making a more comprehensive application of various disinfectants to every surface in drug-critical production environments.

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