FDA Inspection
Spectranetics CorporationSpectranetics Corporation – FDA Inspection, Jan 14, 2009
Record Details
This FDA Inspection record concerns Spectranetics Corporation, with an inspection on January 14, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Spectranetics Corporation
- Inspection Date
- January 14, 2009
- Product Type
- Devices
View Company Profile
ID · 86675e83-2aee-477e-a7dc-3ccc5af05b02
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 571186
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
6- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(a)(4)CAPA verification/validation of corrective/preventive action
- 21 CFR 820.60Identification procedures, Lack of or inadequate procedures
- 21 CFR 820.198(e)(5)Nature and details of complaint
- 21 CFR 820.250(b)Sampling plans
- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of Spectranetics Corporation
4| Date | Classification | Office | Project area |
|---|---|---|---|
| January 13, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 12, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 1, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 12, 2010 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Spectranetics Corporation
- FDA Inspection 970688 - 2016-01-13
- FDA Inspection 835940 - 2013-06-12
- FDA Inspection 711052 - 2011-03-01
- FDA Inspection 653454 - 2010-03-12
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