US regulators have suspended operations at The National Institutes of Health (NIH)’s drug production lab because of serious manufacturing issues.
The US Food and Drug Administration’s move comes after an inspection discovered a litany of problems, including fungal contamination of two vials of albumin used for the administration of the drug interleukin in experimental studies. These were given to six patients, which are now being monitored closely for signs of infection.
Other issues at the facility included flaws in the air handling system, inadequate quality control, insufficient employee training, and failure to comply with standard operating procedures.
“This is a distressing and unacceptable situation,” said NIH Director Francis Collins. “The fact that patients may have been put in harm’s way because of a failure to follow standard operating procedures in the NIH Clinical Center’s Pharmaceutical Development Section is deeply troubling.”
An external group of experts in microbiology and sterile manufacturing practices will now be called in to conduct a thorough review, including an assessment of all standard operating procedures, policies, staffing, and training, and draw up a plan of corrective actions.