# FDA 483 - Reliance Mobility, LLC - April 10, 2018

Source: https://www.keypedia.com/records/483/reliance-mobility-llc/0972d61b-4ba2-4634-a40b-3beb1695030a

> FDA 483 for Reliance Mobility, LLC on April 10, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Reliance Mobility, LLC
- Inspection Date: 2018-04-10
- Product Type: device
- Office Name: New Orleans District Office
- Summary: An FDA inspection of Reliance Mobility, LLC in Columbia, TN, a manufacturer of dedicated speech generating devices, revealed numerous significant deficiencies in its quality system. The firm failed to establish or adequately maintain essential procedures and records for design control, device master and history records, complaint handling, medical device reporting, corrective and preventive actions, and quality audits. These findings indicate a broad lack of compliance with fundamental regulatory requirements for medical device manufacturing.

## Related Documents

- [483 - 2022-05-09](https://www.keypedia.com/records/483/reliance-mobility-llc/25e0c4df-dca6-400d-80a0-f8477f5c94af)

## Related Officers

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

Company: https://www.keypedia.com/companies/reliance-mobility-llc/9cd42cd4-ea6b-4de3-8368-ba6893072778

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