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FDA Inspection 956408 — Spectranetics Corporation

Spectranetics Corporation — FEI 3007284006

The FDA completed an inspection of Spectranetics Corporation on January 21, 2016 in Colorado Springs, CO. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). Product area: Devices.

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
January 21, 2016
Fiscal Year
2016
Product Type
Devices
Project Area
Compliance: Devices
Location
Colorado Springs, CO (United States)

Facility

Other inspections at this facility

  • 1083024 (NAI Fri Mar 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1026732 (VAI Wed Sep 27 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 825660 (NAI Thu Mar 14 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 754488 (NAI Wed Nov 16 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 696646 (VAI Fri Nov 05 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

FDA data resources