FDA Inspection
Synthes, Inc.Synthes, Inc. – FDA Inspection, Nov 13, 2013
Record Details
This FDA Inspection record concerns Synthes, Inc., with an inspection on November 13, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Synthes, Inc.
- Inspection Date
- November 13, 2013
- Product Type
- Devices
View Company Profile
ID · 7545c960-4b20-4836-a8be-c6c88057354e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 859106
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.100(b)Documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Synthes, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| May 16, 2013 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| October 19, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| 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 831886 - 2013-05-16
- FDA Inspection 806156 - 2012-10-19
- FDA Inspection 732622 - 2011-09-15
- FDA Inspection 620039 - 2009-10-08
- FDA Inspection 581756 - 2009-04-27
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