Fungus in drug vials and even insect infestations has forced the National Institutes of Health to suspend operations at one of its research facilities.
The Food and Drug Administration recently inspected the NIH’s Clinical Center late last month and found several quality problems, NIH disclosed Thursday.
The facility, on NIH’s Bethesda campus, makes products for certain clinical research studies in hospitals and other facilities. It will be shuttered until improvements can be made.
FDA investigators found insects in two of five clean room lighting areas last month.
Other problems include two vials of albumin, a protein of human blood, contaminated with fungus.
“Vials made from the same batch were administered to six patients, although it is unknown whether those or other vials were contaminated,” NIH said in a release.
The six patients have been notified but have shown no signs of infection or illness.
All in all, the FDA found 17 “observations” or quality problems at the facility, according to the inspection report. It also found three problems at a hospital pharmacy, such as not cleaning areas properly.
“This is a distressing and unacceptable situation,” said NIH Director Francis Collins.
