# FDA 483 - Mobius Bionics, LLC - November 16, 2022

Source: https://www.keypedia.com/records/483/mobius-bionics-llc/37a18b70-7ce4-4813-9a4a-4628d3335f41

> FDA 483 for Mobius Bionics, LLC on November 16, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mobius Bionics, LLC
- Inspection Date: 2022-11-16
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Mobius Bionics, LLC in Manchester, NH, conducted from November 10-16, 2022, identified one observation. The firm failed to conduct management reviews of its quality system at defined intervals, as required by its own procedures. This indicates a lapse in oversight of the quality system for their Class II medical device.

## Related Documents

- [483 - 2022-11-16](https://www.keypedia.com/records/483/mobius-bionics-llc/e45d90b3-7556-4d5a-b962-a911ed185c41)

## Related Officers

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

Company: https://www.keypedia.com/companies/mobius-bionics-llc/3514a78c-6707-4fb4-a858-8ebdd5266b86

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