NIH Permanently Stops Production at Site Scrutinized by FDA
NIH has permanently suspended trial drug production at its Maryland site where FDA identified GMP violations last year.
A letter from the FDA announced on-going work in NIH’s pharmaceutical development section had been decommissioned as of May 27 due to significant GMP violations. Investigators identified a slew of GMP deficiencies during the investigation, including product contamination, failure to conduct production in defined areas and the lack of an environmental monitoring system.
In response to FDA’s concerns, the government funded research center hired consultants to assess operations at the site and its other additional laboratories.