
NIH Suspends Research in Sterile Production Facilities
The National Institutes of Health (NIH) released a statement on April 19, 2016 saying that it plans to suspend research in two laboratories after preliminary results found the labs not in compliance with CGMP practices.
Updated April 21, 2016
The National Institutes of Health (NIH) released a statement on April 19, 2016 saying that it plans to suspend research in two laboratories after preliminary results found the labs not in compliance with CGMP practices.
This comes after an FDA inspection in May 2015 citing several safety concerns with the facilities’ aseptic processes. In June 2015,
In its
As a result of the shutdown, several companies had to pause clinical trials being conducted in NIH laboratories.
No patients have been harmed as a result of the quality issues, NIH said in its statement. NIH said it plans to undergo a “rigorous review” of the facilities and no new patients will be enrolled until all issues are resolved.
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