# FDA 483 - NuVasive, Inc - March 14, 2014

Source: https://www.globalkeysolutions.net/records/483/nuvasive-inc/ecd002f0-0558-4d40-9819-09299fb00a1f

> FDA 483 for NuVasive, Inc on March 14, 2014. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: NuVasive, Inc
- Inspection Date: 2014-03-14
- Product Type: biologics
- Office Name: New Orleans District Office
- Summary: An FDA inspection of NuVasive, Inc.'s Human Tissue Distribution Center in Memphis, TN, identified one observation. The firm failed to record and maintain storage temperatures for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), specifically Osteocel products, as required by their procedures.

## Related Documents

- [483 - 2017-05-04](https://www.globalkeysolutions.net/records/483/nuvasive-inc/a5b1b8c4-2678-4e2b-898b-29e4f230f731)

## Related Officers

- [Investigator/Consumer Safety Officer](https://www.globalkeysolutions.net/people/francis-a-guidry/fd6d2a17-7f94-4f7c-8284-ad1f07d703e9)

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