FDA Inspection 1011810 — NuVasive Inc

NuVasive Inc — FEI 3002980729

The FDA completed an inspection of NuVasive Inc on May 26, 2017 in San Diego, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Biologics.

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
May 26, 2017
Fiscal Year
2017
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
San Diego, CA (United States)

Citations

IDCFRDescription
310121 CFR 820.30(g)Design validation- Lack of or inadequate procedures
73121 CFR 803.50(a)(1)Report of Death or Serious Injury