FDA publishes Inspection Report for Cells, Tissues and Cell Products
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:
2014 | 2015 | 2016 | 2017 | 2018 | |
NAI Inspections | 524 | 501 | 541 | 561 | 529 |
VAI Inspections | 130 | 97 | 97 | 57 | 93 |
OAI Inspections | 8 | 8 | 5 | 8 | 12 |
Number of Inspections | 652 | 598 | 636 | 621 | 625 |
Av. hours/inspection | 35,4 | 34,4 | 38,1 | 36,9 | 37,8 |
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.
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