Extremely proud! FDA BIMO inspection without any finding
After 3 intense weeks of inspection and 8 weeks of preparation I am extremely proud to report that a FDA BIMO inspection was successful! There were no findings at the clinical sites, nor at the sponsor for the project reported.
I was very involved in this inspection as the project I actively worked on for an extensive time period was in scope. Being in the seat to coordinate the preparation, the past weeks were so exiting and our team did a fantastic job! We had a large team assembled for support (international Clinical and regulatory) as well as cross-functional from different functions.