FDA 483 - DSM Biomedical, Inc. - February 12, 2026

An FDA inspection of DSM Biomedical in Exton, PA, a medical device manufacturer, identified two observations concerning the manufacturing and distribution of Augment Injectable Bone Graft Matrix. The firm was cited for issues related to the validation of a design change and equipment modification, as well as the lack of stability data to support established expiration dates for raw materials.