# FDA 483 - Nevro Corporation - August 13, 2025

Source: https://www.globalkeysolutions.net/records/483/nevro-corporation/c578e95d-2660-44b0-87a6-0bad85c3dd22

> FDA 483 for Nevro Corporation on August 13, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nevro Corporation
- Inspection Date: 2025-08-13
- Product Type: device
- Office Name: San Francisco District Office
- Summary: Nevro Corporation, a medical device manufacturer in Redwood City, CA, was inspected and received a Form FDA-483 with six observations. The inspection revealed significant deficiencies in process validation for re-boxing, inadequate complaint handling and investigation, uncontrolled production processes for packaging, and insufficient design validation for packaging. Additionally, the firm failed to submit Medical Device Reports (MDRs) within the required timeframe and lacked adequate documentation for corrective and preventive actions.

## Related Documents

- [483 - 2017-11-03](https://www.globalkeysolutions.net/records/483/nevro-corporation/b4c81e77-1156-4ba6-9854-95bfecc42b8b)

## Related Officers

- [Shannon A. Gregory](https://www.globalkeysolutions.net/people/shannon-a-gregory/3e791321-dced-4e1d-89a1-3da91d577961)
- [Brittany D. Mccracken](https://www.globalkeysolutions.net/people/brittany-d-mccracken/a869ecee-3b7b-4c1a-8c77-7efb1a3d902a)

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

Office: https://www.globalkeysolutions.net/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df