FDA Inspection
Synthes, Inc.Synthes, Inc. – FDA Inspection, Oct 19, 2012
Record Details
This FDA Inspection record concerns Synthes, Inc., with an inspection on October 19, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Synthes, Inc.
- Inspection Date
- October 19, 2012
- Product Type
- Devices
View Company Profile
ID · 8b68eaea-49dd-47ce-8585-f1c82c466d57
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 806156
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.100(a)Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Synthes, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| November 13, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 16, 2013 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| September 15, 2011 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 8, 2009 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| April 27, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Synthes, Inc.
- FDA Inspection 859106 - 2013-11-13
- FDA Inspection 831886 - 2013-05-16
- FDA Inspection 732622 - 2011-09-15
- FDA Inspection 620039 - 2009-10-08
- FDA Inspection 581756 - 2009-04-27
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