FDA 483 - Amplion Clinical Communications, Inc. - September 08, 2021

An FDA inspection of Amplion Clinical Communications, Inc. in Nashville, TN, a specification developer, revealed significant deficiencies in its quality system. Observations included inadequate procedures for corrective and preventive actions, complaint management, and documentation of design risk analysis. Additionally, the firm failed to adequately maintain its device master record for key components of its nurse call system.