# FDA 483 - NuVasive, Inc - May 04, 2017

Source: https://www.globalkeysolutions.net/records/483/nuvasive-inc/a5b1b8c4-2678-4e2b-898b-29e4f230f731

> FDA 483 for NuVasive, Inc on May 04, 2017. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: NuVasive, Inc
- Inspection Date: 2017-05-04
- Product Type: device
- Office Name: New Orleans District Office
- Summary: An FDA inspection of NuVasive, Inc. in Memphis, TN, a medical device manufacturer, revealed significant deficiencies in their quality management system. Observations included inadequate establishment and implementation of corrective and preventive action procedures, and insufficient control over nonconforming products. Additionally, the firm failed to provide justification for not reporting certain correction or removal actions to the FDA.

## Related Documents

- [483 - 2014-03-14](https://www.globalkeysolutions.net/records/483/nuvasive-inc/ecd002f0-0558-4d40-9819-09299fb00a1f)

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/bonnie-b-conley/9d0d68d2-f40f-455d-a33e-3d5d1e97f295)

Company: https://www.globalkeysolutions.net/companies/nuvasive-inc/7d31c043-5e73-4ebf-b4c3-d1dcfa8306a4

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