FDA 483 - Promade POC Center for Complex Orthopedic Solutions at HHS - January 18, 2024

An FDA inspection of Promade POC Center for Complex Orthopedic Solutions at HSS, a medical device manufacturer in New York, identified one observation related to inadequate maintenance of device history records. The firm failed to properly record lot numbers and work instructions in their recycle blending records for titanium powder, and their device history records contained discrepancies regarding work instruction procedures. This indicates a moderate compliance issue with record-keeping practices.