FDA Inspection
Viper Technologies, LLC dba Avalign ThortexViper Technologies, LLC dba Avalign Thortex – FDA Inspection, Jan 25, 2013
Record Details
This FDA Inspection record concerns Viper Technologies, LLC dba Avalign Thortex, with an inspection on January 25, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- January 25, 2013
- Product Type
- Devices
View Company Profile
ID · faa1005d-5760-41bd-b33b-127eb8ab5563
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 818020
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(i)Software validation for automated processes
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Other FDA inspections of Viper Technologies, LLC dba Avalign Thortex
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 24, 2021 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 1, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 17, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Viper Technologies, LLC dba Avalign Thortex
- FDA Inspection 1153939 - 2021-09-24
- FDA Inspection 967911 - 2016-04-01
- FDA Inspection 680877 - 2010-09-17
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