FDA Inspection
Elwyn IncElwyn Inc – FDA Inspection, Apr 27, 2010
Record Details
This FDA Inspection record concerns Elwyn Inc, with an inspection on April 27, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Elwyn Inc
- Inspection Date
- April 27, 2010
- Product Type
- Devices
View Company Profile
ID · e1936cdf-825d-4263-a820-0c848fff4789
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 662987
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.198(a)General
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.100(a)(2)Investigation procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Elwyn Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 21, 2017 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 28, 2009 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 12, 2008 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Elwyn Inc
- FDA Inspection 1032372 - 2017-11-21
- FDA Inspection 558169 - 2009-01-28
- FDA Inspection 547557 - 2008-11-12
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