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FDA Inspection
•NuVasive Inc•December 2, 2008

NuVasive Inc – FDA Inspection, Dec 2, 2008

Record Details

This FDA Inspection record concerns NuVasive Inc, with an inspection on December 2, 2008, issued by the Center for Devices and Radiological Health, covering devices.

Company
NuVasive Inc
Inspection Date
December 2, 2008
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · d0196b3b-5e61-43e9-837a-89f12a2dec54

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
548750
FDA center
Medical Devices & Rad Health
Project area
Bioresearch Monitoring

FDA Citations

1
  1. 21 CFR 812.43(c)(4)(iii)No informed consent statement in investigator agreement

Full citation text and observation details available on the Dashboard.

Other FDA inspections of NuVasive Inc

7
DateClassificationOfficeProject area
May 26, 2017VAICenter for Devices and Radiological HealthCompliance: Devices
November 19, 2014NAICenter for Devices and Radiological HealthBioresearch Monitoring
February 5, 2014NAICenter for Devices and Radiological HealthCompliance: Devices
November 2, 2012OAICenter for Devices and Radiological HealthCompliance: Devices
February 10, 2012NAICenter for Devices and Radiological HealthBioresearch Monitoring
View all 7 other inspections on the company page
Other documents for NuVasive Inc
  • FDA Inspection 1011810 - 2017-05-26
  • FDA Inspection 904804 - 2014-11-19
  • FDA Inspection 865024 - 2014-02-05
  • FDA Inspection 805149 - 2012-11-02
  • FDA Inspection 768996 - 2012-02-10

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