The National Institutes of Health is scrambling to clean up a manufacturing plant that was chided by federal inspectors and suspended certain operations.
The NIH’s Clinical Center suspended operations for its sterile drug manufacturing facility earlier this month in response to Food and Drug Administration inspections that uncovered fungus in drug vials and even insect infestation. The agency said Friday it will hire independent experts to address the manufacturing problems.
NIH also will create an independent group of advisers that will make recommendations on how to address the FDA’s concerns.
The center is on NIH’s campus in Bethesda, Md., and makes products for certain clinical research studies in hospitals and other facilities.
In May, FDA investigators found insects in two of five clean room lighting areas. Vials of a protein of human blood also were contaminated with fungus, according to the inspection report.
NIH hopes to make significant improvements by the end of September but didn’t elaborate on when the manufacturing center and a connected pharmacy may resume operations.
