FDA 483 - Safer Medical Products Inc. - October 08, 2025

Safer Medical Products Inc. in Fircrest, WA, a specification developer, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to establish design history files and maintain device history records for its Safer Portable Vacuum device. Additionally, the company did not ensure proper unique device identification (UDI) labeling and registration for its medical devices.