Sterility Fears at the NIH
How did the NIH get it so wrong – and how can it move on?
Stephanie Sutton |
Aseptic processing is a complex art and it seems no one is immune to problems– or the resulting publicity backlash – including the US National Institutes of Health (NIH). At the start of June, NIH had to shut down sterile operations at its Pharmaceutical Development Section (PDS) after an FDA inspection identified several problems, including fungus contamination in vials of albumin. Drugs from the same batch have already been administered to patients in clinical research programs, who are now being closely monitored.
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