FDA Inspection
Leica Biosystems Newcastle Ltd.Leica Biosystems Newcastle Ltd. – FDA Inspection, Apr 27, 2017
Record Details
This FDA Inspection record concerns Leica Biosystems Newcastle Ltd., with an inspection on April 27, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · a3a3c1be-ae78-46d9-bead-4495c5299463
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1016878
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of Leica Biosystems Newcastle Ltd.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 25, 2019 | Not classified | Office of Inspections and Investigations | |
| June 5, 2014 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| November 5, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Leica Biosystems Newcastle Ltd.
- FDA Inspection 1093975 - 2019-01-25
- FDA Inspection 883111 - 2014-06-05
- FDA Inspection 629656 - 2009-11-05
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