FDA Releases 2023 HCT/P Inspection Summary

May 08, 2024

The Food and Drug Administration released inspection information for human cells, tissues, and cellular and tissue-based products (HCT/Ps) establishments for fiscal years 2019-23. There were 563 inspections in 2019, 287 in 2020, 159 in 2021, 379 in 2022 and 445 in 2023. The summary also includes the number of inspections in which official action was indicated (OAI), voluntary action was indicated or no action was indicated. Despite the increased number of inspections in 2023, FDA noted a decrease in the proportion of inspections classified as OAI, meaning objectionable conditions were found and regulatory action should be recommended