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FDA Inspection 696646 — Spectranetics Corporation

Spectranetics Corporation — FEI 3007284006

The FDA completed an inspection of Spectranetics Corporation on November 5, 2010 in Colorado Springs, CO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 5, 2010
Fiscal Year
2011
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Colorado Springs, CO (United States)

Facility

Other inspections at this facility

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  • 1026732 (VAI Wed Sep 27 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 956408 (OAI Thu Jan 21 2016 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))

Recent compliance actions

FDA data resources