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

Source: https://www.globalkeysolutions.net/records/483/amplion-clinical-communications-inc/389d4dd7-6f9d-4e81-8575-4b9e65878dea

> FDA 483 for Amplion Clinical Communications, Inc. on September 08, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Amplion Clinical Communications, Inc.
- Inspection Date: 2021-09-08
- Product Type: device
- Office Name: New Orleans District Office
- Summary: 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.

## Related Documents

- [483 - 2019-09-04](https://www.globalkeysolutions.net/records/483/amplion-clinical-communications-inc/b54e3be6-5d11-49b1-b39e-69cbf9f2b3c6)
- [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)
- [investigator](https://www.globalkeysolutions.net/people/nikki-s-bryant/fe859d4f-23a6-4bc9-94c6-5b3c3fe8d99a)

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