BIMO inspection NYC
LyncoClinical provided back-office support for a BIMO inspection in NYC.
Data from the project in scope was used in a PMA label expansion file.
The vendor inspected was contracted to perform independent imaging analysis and had safety related responsibilities.
The inspection was announced 24th July to start early July 31st. Togheter with a colleague JacobsConsulting I was requested to join this inspection in the back office located in NYC.
It was this vendor first FDA inspection and althought the team managed wonderfully to respond to all the inspectors questions, the presence from us as 2 BIMO-experienced colleagues was highly appreciated.
Beyond the inspection time in this wondeful location, LyncoClinical and JacobsConsulting both had ample of time to explore the city in the evening and to have some great afterwork time with the NewYork colleagues.
Thanks to the project sponsor for this wonderful experience :-)
Lien & Sigie