FDA publishes Inspection Report for Cells, Tissues and Cell Products
On the Road to 30,000 Members
Let us become the World's Leading GMP/GDP Compliance Community in 2026
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.
Related GMP News
22.04.2026What are the GMP Requirements for ATMPs?
25.03.2026What are the GMP Requirements for Biotechnological Products?
18.03.2026Latest FDA Updates: Biosimilar Development Guidance
18.03.2026ECA ATMP Group publishes position paper on specifications considering patient-centricity
11.12.2025Utility of Comparative Efficacy Studies in Biosimilar Development
03.09.2025Standardisation of Monoclonal Antibodies (mAbs) by the EPC