FDA Inspection
AstroNovaAstroNova – FDA Inspection, Feb 25, 2011
Record Details
This FDA Inspection record concerns AstroNova, with an inspection on February 25, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- AstroNova
- Inspection Date
- February 25, 2011
- Product Type
- Devices
View Company Profile
ID · ac617d7e-9f09-4612-a5b5-5125574bcb20
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 712990
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.70(i)Software validation for automated processes
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Other FDA inspections of AstroNova
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 19, 2013 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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