FDA Inspection
On-X Life Technologies, Inc.On-X Life Technologies, Inc. – FDA Inspection, Jul 3, 2013
Record Details
This FDA Inspection record concerns On-X Life Technologies, Inc., with an inspection on July 3, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- On-X Life Technologies, Inc.
- Inspection Date
- July 3, 2013
- Product Type
- Devices
View Company Profile
ID · f9b52255-ed85-4a33-8306-73eb320894ad
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 839395
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
1- 21 CFR 812.43(c)No investigator agreement
Full citation text and observation details available on the Dashboard.
Other FDA inspections of On-X Life Technologies, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 15, 2017 | Not classified | Dallas District Office | |
| August 4, 2017 | Not classified | Dallas District Office | |
| January 6, 2011 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| April 30, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for On-X Life Technologies, Inc.
- FDA Inspection 1029684 - 2017-08-15
- FDA Inspection 1025177 - 2017-08-04
- FDA Inspection 706450 - 2011-01-06
- FDA Inspection 580461 - 2009-04-30
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