BIMO inspection NYC
LyncoClinical provided back-office support for a BIMO inspection in NYC.
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.
Lien & Sigie