How many FDA inspections still take place in the EU?

Recommendation

14-16 June 2023
Copenhagen, Denmark

The GMP-Auditor
Initial and Continuous Professional Training for GMP Auditors

Since July 2019, the MRA (Mutual Recognition Agreement) between the EU and the US FDA has been fully in force. One of the main objectives was to mutually recognise the respective GMP inspection systems and reduce the number of foreign inspections.

But has the number of FDA inspections really decreased? A very good source is the FDA Data Dashboard. This detailed overview of FDA activities carried out provides easy-to-use and understandable tables and graphs for comprehensive analysis.

According to the dashboard, quite some "Drug Quality Assurance" inspections were conducted or completed at firms in the EU in 2021 - despite the pandemic and MRA. And pre-approval inspections are not even listed here.

Here is an overview of the number of inspections in EU Member States with the most FDA inspections in the area of "Drug Quality Assurance":

With a slight time lag, one also finds the observations from the inspections. Thus, among others, the following observations were made recently at the inspected companies:

• "Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up."
• "Procedures describing the handling of written and oral complaints related to drug products are not written or followed."
• "There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch … to meet any of its specifications…"
• "Batch production and control records do not include complete information relating to the production and control of each batch."

The complete inspection histories for the individual companies can be called up in this database as well.