FDA Inspection
ANT North America IncANT North America Inc – FDA Inspection, Dec 7, 2012
Record Details
This FDA Inspection record concerns ANT North America Inc, with an inspection on December 7, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- ANT North America Inc
- Inspection Date
- December 7, 2012
- Product Type
- Devices
View Company Profile
ID · 460b56e1-b0bc-4d0d-803f-d49b476d1e90
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 811279
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.25(a)Personnel
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.150Lack of or inadequate procedures for storage.
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of ANT North America Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 10, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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