# FDA 483 - NextPhase Medical Devices LLC - January 10, 2022

Source: https://www.keypedia.com/records/483/nextphase-medical-devices-llc/3931d548-a4ef-4110-906e-cded9d4dd9c3

> FDA 483 for NextPhase Medical Devices LLC on January 10, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: NextPhase Medical Devices LLC
- Inspection Date: 2022-01-10
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of NextPhase Medical Devices LLC in Rochester, NH, from January 4-10, 2022, identified one significant observation. The firm failed to adequately establish procedures for controlling storage areas and stock rooms, resulting in expired product intended for assembly not being properly quarantined or designated as unacceptable for use.

## Related Officers

- [Sara M. Onyango](https://www.keypedia.com/people/sara-m-onyango/643c6ad3-9747-4bc2-9e8e-72f97b11e659)

Company: https://www.keypedia.com/companies/nextphase-medical-devices-llc/3c3e80cb-ef86-4105-9a5e-f41092e37232

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94