As a result of inept manufacturing policies and evidence of fungal contamination, government inspection teams have closed a drug manufacturing facility, at the United States National Institutes (NIH), of Health, in Bethesda, Maryland.
Daniel Amen mentioned the fact that manufacturing and coordination of the distribution of unproven, exploratory and developmental drugs, is under the jurisdiction of the Pharmaceutical Development Section, and facilitates substances for more than 45 trials. Lawrence Tabak, principal deputy director of the NIH commented, “Out of an abundance of caution, we’ve suspended use of all these products.”
Revealed during the subsequent investigation, six patients are being closely observed, ass a result of receiving protein albumin, from a manufactured lot, in which two vials were discovered to have fungal contamination.
Food and Drug Administration inspectors confirmed violations regarding training and quality control regulations as well as workplace attire, and skin exposure prevention mandates. The facility was supposedly decontaminated and cleaned, with chemical solvents, that were unable to eradicate bacterial spores and fungi. A review of facility documents indicated poor record keeping for testing water quality, and registering airflow data, in ventilation systems, designed to halt microbes from containment hood dispersal.
“It’s troubling that an institution of NIH’s caliber had such serious deficiencies,” says Michael Carome, director of health research at Public Citizen, a non-profit watchdog organization in Washington DC. “These clearly could have put patients at risk of harm.”