FDA Inspection
Axis-Shield Diagnostics, Ltd.Axis-Shield Diagnostics, Ltd. – FDA Inspection, Oct 25, 2018
Record Details
This FDA Inspection record concerns Axis-Shield Diagnostics, Ltd., with an inspection on October 25, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ac07dcc6-37d6-4778-ab39-ea1e6002ab79
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1072250
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
- 21 CFR 820.70(g)Equipment design and installation
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Other FDA inspections of Axis-Shield Diagnostics, Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 23, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Axis-Shield Diagnostics, Ltd.
- FDA Inspection 988580 - 2016-06-23
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