FDA Inspection
UE LifeSciences Inc.UE LifeSciences Inc. – FDA Inspection, Oct 26, 2015
Record Details
This FDA Inspection record concerns UE LifeSciences Inc., with an inspection on October 26, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- UE LifeSciences Inc.
- Inspection Date
- October 26, 2015
- Product Type
- Devices
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ID · 7f5c3b71-8cca-4644-ac3d-d69542fc15bd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 948445
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.40(a)Document review, approval documentation
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Other FDA inspections of UE LifeSciences Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 7, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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