FDA Inspection 1028593 — Spinal Elements, Inc

Spinal Elements, Inc — FEI 3004893332

The FDA completed an inspection of Spinal Elements, Inc on Sep 29, 2017 in Carlsbad, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 1 citation was issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI)
End Date
Sep 29, 2017
Fiscal Year
2017
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Carlsbad, CA (United States)

Citations

IDCFRDescription
265021 CFR 820.30(f)Design verification - Lack of or inadequate procedures

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.