FDA Inspection
Spectranetics CorporationSpectranetics Corporation – FDA Inspection, Jan 21, 2016
Record Details
This FDA Inspection record concerns Spectranetics Corporation, with an inspection on January 21, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Spectranetics Corporation
- Inspection Date
- January 21, 2016
- Product Type
- Devices
View Company Profile
ID · b3d1e217-0bf9-4ecb-bb73-10a04d740eb7
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 956408
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
Other FDA inspections of Spectranetics Corporation
6| Date | Classification | Office | Project area |
|---|---|---|---|
| March 1, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 27, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 14, 2013 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| November 16, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 5, 2010 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Spectranetics Corporation
- FDA Inspection 1083024 - 2019-03-01
- FDA Inspection 1026732 - 2017-09-27
- FDA Inspection 825660 - 2013-03-14
- FDA Inspection 754488 - 2011-11-16
- FDA Inspection 696646 - 2010-11-05
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