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

Source: https://www.globalkeysolutions.net/records/483/amplion-clinical-communications-inc/b54e3be6-5d11-49b1-b39e-69cbf9f2b3c6

> FDA 483 for Amplion Clinical Communications, Inc. on September 04, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Amplion Clinical Communications, Inc.
- Inspection Date: 2019-09-04
- Product Type: device
- Office Name: New Orleans District Office
- Summary: 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.

## Related Documents

- [483 - 2021-09-08](https://www.globalkeysolutions.net/records/483/amplion-clinical-communications-inc/389d4dd7-6f9d-4e81-8575-4b9e65878dea)
- [483 - 2023-02-16](https://www.globalkeysolutions.net/records/483/amplion-clinical-communications-inc/27985aa0-8863-44d5-84cb-338c12fac6a8)

## Related Officers

- [Mary A. Millner](https://www.globalkeysolutions.net/people/mary-a-millner/bd8911cf-849d-41d2-ae12-dd4bad66e798)

Company: https://www.globalkeysolutions.net/companies/amplion-clinical-communications-inc/9de142e5-9171-405f-bf2c-890e2a0b5f93

Office: https://www.globalkeysolutions.net/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea