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FDA cites 17 observations including air handling, quality control, and deficient microbial monitoring at NIH’s Clinical Center Pharmaceutical Development Section.
The discovery of fungal contamination in two vials of albumin manufactured at the National Institutes of Health (NIH) Clinical Center Pharmaceutical Development Section (PDS) has resulted in an FDA inspection and suspension of operations at the facility.
NIH reported the shutdown due to “the discovery of serious manufacturing problems and lack of compliance with standard operating procedures” in a statement. Upon receipt of a complaint, NIH reports, FDA representatives inspected the facility in May and found a series of deficiencies that will require corrective actions.
The PDS facility makes products for clinical research studies conducted in the hospital and collaborating facilities. In April, two vials of albumin, used for the administration of the drug interleukin in experimental studies, were found to have fungal contamination. Vials made from the same batch were administered to six patients; it is unknown whether those or other vials were contaminated. The affected patients have been notified and are being monitored for signs of infection. At this time, none has developed signs of infection or illness, NIH reports.
“This is a distressing and unacceptable situation,” said NIH Director Francis S. Collins, MD, PhD, in the statement. “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.”
FDA’s inspection identified 17 observations, as reported in a Form 483 report. Observations included deficiencies in the physical facility, including flaws in the air handling system, a lack of monitoring for microbial contamination and particles, operational failures including inadequate quality control, insufficient employee training, and lack of compliance with standard operating procedures the lack of a written testing program to assess the stability characteristics of drug product, a lack of container-closure integrity testing, and deficiencies in microbial testing.
The Clinical Center Pharmacy was cited for improper gowning and cleaning procedures, deficient systems for maintaining equipment used to control aseptic conditions in the aseptic processing areas, and inadequate separation of aseptic processing from the common pharmacy operations, and insufficient containment in the chemotherapeutic drug production area.
In its statement, NIH reports that no products will be made or distributed until all problems are understood and corrected. Materials are being tested for contamination. External experts in microbiology and sterile manufacturing practices will be appointed to conduct a review of standard operating procedures, policies, staffing, and training, and make recommendations on the corrective actions required.
NIH reports it has notified the principal scientists responsible for 46 studies that are potentially affected by drug shortages due the to shutdown and is working to secure alternative sources for the products.
NIH plans to provide an interim corrective action plan to FDA by June 19, 2015.