Positron emission tomography (PET) firm PETNET Solutions was hit with an FDA warning letter for serious violations including “a state of disrepair and lack of cleanliness” at its Woburn, Massachusetts facility.
An FDA inspection found the facility was run down. For example, rusted screws were seen around a light fixture in an ISO 5 area where PET drug products were aseptically filled, and a three-inch hole was noted at the top of an enclosure in the ISO 5 area, open to the room and with dirt visible around it.
The agency noted the continued growth of spore forming organisms that were previously observed in the facility in March 2016. Fungi were repeatedly identified in an ISO 8 area during a third-party certification.