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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