Tuesday, 13 June 2023 13.00 - 17.45 h
The US FDA has recently introduced a new service on their webpage. A new "inspection dashboard" provides information and analysis about the inspections which have been performed by the FDA in the previous years.
According to the FDA, the tool allows to share "inspectional, compliance and enforcement related data in various, easily understood graphical formats. The tool allows users to drill down on elements within the graphical formats for a more detailed view and to export the graphs and underlying data."
Inspectional and compliance data are refreshed on a semi-annual basis and only include final actions. One part of the dashboard delivers summary reports and trends. The other part provides information about inspections in the different countries. The data provided are an interesting step forward in making inspection information available to interested parties. However, the original data sources are not provided. Although the dashboard allows exporting the data, very few additional benefit is given. The data for export are only those to generate the diagrams. This does not allow making any further evaluation. Further improvement would be very helpful. Also separated data for the different areas (e.g. API, Biologics, Drugs etc) would be valuable.
Source: FDA Inspection Dashboard