FDA Inspection
UMA, Inc.UMA, Inc. – FDA Inspection, May 31, 2017
Record Details
This FDA Inspection record concerns UMA, Inc., with an inspection on May 31, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 850e5c67-9527-4a35-90df-8f0bf0cc96c0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1016417
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of UMA, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 21, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 10, 2008 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for UMA, Inc.
- FDA Inspection 1118756 - 2019-11-21
- FDA Inspection 545897 - 2008-11-10
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