FDA Inspection
Synthes (USA), LLCSynthes (USA), LLC – FDA Inspection, Feb 25, 2009
Record Details
This FDA Inspection record concerns Synthes (USA), LLC, with an inspection on February 25, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Synthes (USA), LLC
- Inspection Date
- February 25, 2009
- Product Type
- Devices
View Company Profile
ID · 7e1b1d5a-1002-4486-b69f-1584f8dbc7e3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 565017
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)(4)CAPA verification/validation of corrective/preventive action
- 21 CFR 820.80(d)(2)Review of data and documentation
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Other FDA inspections of Synthes (USA), LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 18, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 8, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 1, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Synthes (USA), LLC
- FDA Inspection 999208 - 2017-01-18
- FDA Inspection 926215 - 2015-05-08
- FDA Inspection 765879 - 2012-02-01
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