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

Recommendation

7/8 May 2024

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Regulatory Requirements and Practical Implementation

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.

The number of  inspections indicating an official action was decreasing in these 5 years. See also the complete data at HCT/P Inspection Information.