26/27 November 2019
Beginning of April, the FDA published the updated data on the inspections of manufacturers and establishments working with Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P's) performed in Fiscal Years 2014 to 2018. This report is published regularly (see also "FDA Information about Human Cell and Tissue (HCT/P) related Inspections" ) and is based on 625 Inspections for the Fiscal Year 2018.
The current data are shown in the following table:
|Number of Inspections||652||598||636||621||625|
NAI = No Action Indicated, meaning no objectionable conditions or practices were found during the inspection (or the significance of the documented objectionable conditions found does not justify further action).
VAI = Voluntary Action Indicated, meaning objectionable conditions were found and documented but the agency is not prepared to take or recommend regulatory action.
OAI = Official Action Indicated, meaning objectionable conditions were found and regulatory action should be recommended
More information can be found on the FDA website at HCT/P Inspection Information.