483
DSM Biomedical, Inc.FDA 483 - DSM Biomedical, Inc. - February 12, 2018
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Record Details
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.
Open in Dashboard
ID · d8755ce2-7ada-4b45-9fba-60afd2b125c9