FDA Inspection
Elwyn IncElwyn Inc – FDA Inspection, Nov 21, 2017
Record Details
This FDA Inspection record concerns Elwyn Inc, with an inspection on November 21, 2017, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · a7fb92d1-1956-4bf7-9063-9b85fb371c1e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1032372
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.72(a)Equipment control activity documentation
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.22Quality Audit/Reaudit - conducted
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Elwyn Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 27, 2010 | VAI | Center for Devices and Radiological Health | Compliance: 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 662987 - 2010-04-27
- FDA Inspection 558169 - 2009-01-28
- FDA Inspection 547557 - 2008-11-12
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.