FDA Inspection
RegeneRegene – FDA Inspection, Apr 7, 2016
Record Details
This FDA Inspection record concerns Regene, with an inspection on April 7, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Regene
- Inspection Date
- April 7, 2016
- Product Type
- Devices
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ID · e3950ac6-ed0c-43c0-92b3-af572ff8aeb3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 968144
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.60Identification procedures, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Regene
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 13, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Regene
- FDA Inspection 823008 - 2013-03-13
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