13/14 October 2021
Earlier this year, the U.S. Food and Drug Administration published a short notice about the Inspections relating to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P's) performed in the Fiscal Years 2012 - 2016. In these years, the FDA performed between 592 and 671 inspections per year. Instead of 2012, where nearly 30% of the inspections indicated a voluntary or official action, more than 80% of the inspection results in no indicated action. The report classified the inspection in the following three groups:
|Number of Inspections||592||671||652||598||636|
|Inspections Classified NAI||432||520||524||501||541|
|Inspections Classified VAI||151||145||130||97||97|
|Inspections Classified OAI||15||13||8||8||5|
|Avg. hours per Inspection||39,4||40,1||35,4||34,4||38,1|
The number of inspections indicating an official action was decreasing in these 5 years. See also the complete data at HCT/P Inspection Information.