FDA Inspection
NuVasive, IncNuVasive, Inc – FDA Inspection, May 4, 2017
Record Details
This FDA Inspection record concerns NuVasive, Inc, with an inspection on May 4, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Bonnie E. Conley (Issuing Officer)
View Company Profile
ID · 9852a64e-b576-45f3-9b44-d56e524a3d2f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1011333
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 806.20(b)(4)Justification for not reporting
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product control
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Other FDA inspections of NuVasive, Inc
11| Date | Classification | Office | Project area |
|---|---|---|---|
| January 30, 2024 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 7, 2020 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 29, 2019 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| January 19, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 26, 2014 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for NuVasive, Inc
- FDA Inspection 1229391 - 2024-01-30
- FDA Inspection 1120583 - 2020-02-07
- FDA Inspection 1101121 - 2019-07-29
- FDA Inspection 1002060 - 2017-01-19
- FDA Inspection 885327 - 2014-06-26
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