FDA 483 - Amplion Clinical Communications, Inc. - September 04, 2019

An FDA inspection of Amplion Clinical Communications, Inc. in Nashville, TN, revealed significant deficiencies across multiple quality system areas related to their Amplion Care Assurance Nurse Call System. The firm was cited for inadequate risk analysis, poor documentation of corrective and preventive actions, and failures in establishing procedures for design changes, design transfer, and design output. Additionally, issues were noted in complaint handling and the lack of Unique Device Identifier (UDI) implementation.