FDA 483 - DRW Medical - April 07, 2025

DRW Medical, a manufacturer in Aston, PA, was inspected regarding its Class II NAPA LP-15 Airway Pressure monitor. The inspection revealed significant deficiencies in the firm's design control process, including a failure to complete required design input, output, and transfer checklists. Additionally, the firm lacked adequate justification or validation for software changes made to the device, raising concerns about its safety and effectiveness for neonates.