A series of operational deficiencies have forced the National Institutes of Health Clinical Center to suspend operations in its Pharmaceutical Development Section (PDS) and will require the NIH to take a number of corrective actions before reopening, according to an announcement.
Representatives from the Food and Drug Administration inspected the PDS between May 19 and May 29 after receiving a complaint. The investigation revealed a number of deficiencies within a lab, including flaws in the air-handling system, as well as operational failures such as inadequate quality control, insufficient employee training, and lack of compliance with standard operating procedures.
That lab makes products used in research studies conducted at the Clinical Center and collaborating institutes. In April, two vials of albumin prepared by the lab for patient use were found have fungal contamination. Six patients may have been exposed to potentially contaminated product and are being monitored closely for any signs of infection. None has developed signs of infection or illness at this time.
The FDA inspection reports are available here .
