FDA Inspection
O'Ryan Industries IncO'Ryan Industries Inc – FDA Inspection, Jan 19, 2011
Record Details
This FDA Inspection record concerns O'Ryan Industries Inc, with an inspection on January 19, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- O'Ryan Industries Inc
- Inspection Date
- January 19, 2011
- Product Type
- Devices
View Company Profile
ID · e5571f50-bf5b-4735-806b-e0719fcc0bf4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 710628
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
21- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.160(a)Lack of or inadequate procedures for distribution
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
Showing 10 of 21 citations.
Full citation text and observation details available on the Dashboard.
Other FDA inspections of O'Ryan Industries Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 26, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for O'Ryan Industries Inc
- FDA Inspection 778753 - 2012-04-26
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.