FDA 483 - Best Nomos - May 08, 2025

Best Nomos, a medical device manufacturer in Pittsburgh, PA, was inspected by the FDA and received a Form 483 with three observations. The inspection revealed significant deficiencies in the firm's quality system, specifically regarding the investigation of device complaints, the establishment of adequate corrective and preventive actions, and the thoroughness of its risk analysis for the BATCAM Optical Tracking System.