# FDA 483 - Nevro Corporation - November 03, 2017

Source: https://www.globalkeysolutions.net/records/483/nevro-corporation/b4c81e77-1156-4ba6-9854-95bfecc42b8b

> FDA 483 for Nevro Corporation on November 03, 2017. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nevro Corporation
- Inspection Date: 2017-11-03
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: An FDA inspection of Nevro Corporation in Redwood City, CA, revealed multiple significant quality system deficiencies. The firm failed to adequately report medical device adverse events, establish effective corrective and preventive actions, and conduct proper risk analysis. Additionally, complaint investigations were insufficient, and the ethylene oxide sterilization process was not adequately validated.

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## Related Officers

- [Founder and Chief Executive Officer](https://www.globalkeysolutions.net/people/adam-s-freeman/8bbc5e50-32c6-4559-b5c9-01b88d102450)

Company: https://www.globalkeysolutions.net/companies/nevro-corporation/6d7059fd-516e-436a-a674-209ff30a5b2c

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b