FDA Inspection
Nouvag AgNouvag Ag – FDA Inspection, Jun 21, 2018
Record Details
This FDA Inspection record concerns Nouvag Ag, with an inspection on June 21, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 60fbb67e-e114-4393-9264-99605dc0db63
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1057371
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of Nouvag Ag
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 12, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Nouvag Ag
- FDA Inspection 970047 - 2016-05-12
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