FDA Inspection
Synthes, Inc.Synthes, Inc. – FDA Inspection, Sep 15, 2011
Record Details
This FDA Inspection record concerns Synthes, Inc., with an inspection on September 15, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Synthes, Inc.
- Inspection Date
- September 15, 2011
- Product Type
- Devices
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ID · 9da0f22e-5ccb-4993-89dc-0729f89395aa
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 732622
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
10- 21 CFR 803.52(f)(6)Evaluation Codes
- 21 CFR 803.50(b)(1)Reporting Information Reasonably Known
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 803.56Submission of Supplement to Individual Report Within One Month
- 21 CFR 820.198(d)Records of MDR Investigation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 803.17(a)(3)Lack of System for Timely Submission of Reports
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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 |
| October 19, 2012 | VAI | Center for Devices and Radiological Health | Compliance: 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 806156 - 2012-10-19
- FDA Inspection 620039 - 2009-10-08
- FDA Inspection 581756 - 2009-04-27
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