FDA Inspection
Spectranetics CorporationSpectranetics Corporation – FDA Inspection, Sep 27, 2017
Record Details
This FDA Inspection record concerns Spectranetics Corporation, with an inspection on September 27, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ccc476d0-107e-48a1-8353-ebf30dcfeea9
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1026732
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of Spectranetics Corporation
6| Date | Classification | Office | Project area |
|---|---|---|---|
| March 1, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 21, 2016 | OAI | Center for Devices and Radiological Health | Compliance: 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 956408 - 2016-01-21
- FDA Inspection 825660 - 2013-03-14
- FDA Inspection 754488 - 2011-11-16
- FDA Inspection 696646 - 2010-11-05
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