FDA Information about Human Cell and Tissue (HCT/P) related Inspections

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:

  • 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.

2012 2013 2014 2015 2016
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.

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