The National Institutes of Health (NIH) Clinical Center announced the suspension of its Pharmaceutical Development Section (PDS) due to manufacturing problems and lack of compliance with standard operating procedures.
The Food and Drug Administration (FDA) investigated a complaint, and found a number of deficiencies at the PDS. The facility manufactures products for clinical research studies.
In April, two vials of albumin (used for administration of the drug interleukin in experimental studies) were found to be contaminated with fungus. Vials from the same batch had been administered to six patients, but it is unknown if those vials were also contaminated. The patients have been notified and are being monitored for the development of infection.
"This is a distressing and unacceptable situation," said NIH Director Francis S. 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. I will personally oversee the steps to protect the safety of patients and remedy the situation as swiftly as possible."
The FDA also uncovered flaws in the air handling system, instances of insufficient employee training, and lack of compliance with standard operating procedures, among other smaller deficiencies.
The facilities will now suspend all production, notify any scientists scheduled to use potentially-affected products manufactured by the PDS on patients, conduct a thorough review of the discrepancies, and provide and provide an interim corrective action plan to the FDA by Friday, June 19, 2015.
"Our first responsibility is the safety and care of our patients," Collins said. "NIH leadership is determined to identify and correct all of the deficiencies that have led to this situation."
See the full inspection report HERE.
