FDA Inspection
UMI IntlUMI Intl – FDA Inspection, Oct 20, 2022
Record Details
This FDA Inspection record concerns UMI Intl, with an inspection on October 20, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- UMI Intl
- Inspection Date
- October 20, 2022
- Product Type
- Devices
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ID · ce203b8f-83b4-4014-b300-f0a51c891fe7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1182339
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- 21 CFR 820.80(b)Incoming acceptance records, documentation
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of UMI Intl
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 31, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 18, 2009 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for UMI Intl
- FDA Inspection 784110 - 2012-05-31
- FDA Inspection 629622 - 2009-11-18
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