FDA 483 - NanoString, A Bruker Company - August 09, 2024

An FDA inspection of NanoString, A Bruker Company, in Seattle, WA, revealed significant deficiencies in the firm's complaint handling procedures. The company failed to adequately maintain complaint files and did not comply with its own standard operating procedures for complaint handling in multiple instances. This included insufficient documentation regarding corrective and preventive actions (CAPA) and assessments for Medical Device Reporting (MDR) requirements.