Norwood Medical, LLC – FDA 483, Apr 17, 2026

Norwood Medical, LLC, a medical device manufacturer in Dayton, OH, was inspected by the FDA and received a Form 483. The inspection revealed significant issues with the firm's supplier management, including inadequate planning for monitoring and re-evaluation, and failures in qualifying suppliers and documenting changes. Additionally, the firm's risk management activities related to product realization were found to be inadequately maintained, with deficiencies in updating Process Failure Mode and Effects Analysis (pFMEA) and defining severity rankings.