The US National Institutes of Health has halted production in two of its facilities due to contamination concerns, NPR reports.
According to NIH, work at a National Cancer Institute laboratory involved in cell therapy production and a National Institute of Mental Health facility that develops positron emission tomography materials has been suspended.
This, NPR notes, comes on the heels of the NIH Clinical Center being shut down last year after fungal contaminants were discovered within two vials of albumin manufactured by the center's Pharmaceutical Development Service. After that finding and an FDA inspection that uncovered deficiencies — including insects in the lights of clean rooms and inadequate training of staff — NIH embarked on an internal investigation. That found that these issues were widespread, NPR says.
"We learned that there was a prior history of contamination events and a systemic failure to adhere to a set of standard safety and compliance principles," the NIH task force said. "Instead, priority had been put on producing a high volume of products to meet the requests of intramural investigators."
Because of that, NIH put together a team to further examine the structural and cultural issues contributing to the problems as well as investigate other NIH sites that manufacture compounds for patients. This review, Stat News notes, lead to this most recent finding of contamination.
While NIH says "there is no evidence that any patients have been harmed," it is undergoing a clinical review and "will not enroll new patients in affected trials until the issues are resolved."