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.
Words from the Vice President to our team:
"Once again, thank you for the extraordinary effort you put in over the last several weeks that resulted in three weeks of BiMo inspections with no findings. I was so inspired by the attitude and drive to win you all had, and I know that your passion and commitment is what made the difference. We were certainly prepared and the data set and sites were in good shape. But as you all know, there is always a way to find a problem in the magnitude of what we deal with, if someone wants to. I lived in that front room for one week, and I perceived that this inspector was inspired and impressed by your determination, your willingness to not let anything go, your preparation and passion. It got tough at times, but ultimately our perseverance and determination in showing why we thought things were handled correctly prevailed and this resulted in the great outcome. I will go as far as saying that I really had fun last week. It was so special to see your commitment, tension and drive.Thank you all for believing and delivering a great result!"