FDA 483 - Surmodics Inc - November 04, 2021

An FDA inspection of Surmodics Inc, a medical device sponsor in Eden Prairie, MN, revealed significant deficiencies in their management of investigational devices. The firm failed to account for all unused Surveil drug coated balloon catheters at the conclusion of a study and lacked written procedures for device accountability. These observations indicate a failure to maintain accurate and complete records for device disposition.