FDA Inspection
Synthes (USA) Products LLCSynthes (USA) Products LLC – FDA Inspection, Oct 13, 2017
Record Details
This FDA Inspection record concerns Synthes (USA) Products LLC, with an inspection on October 13, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d8969994-3d91-441a-a963-512c8f7b20cd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1028729
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 803.50(b)(1)Reporting Information Reasonably Known
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Synthes (USA) Products LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| October 20, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 17, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 25, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 29, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 27, 2009 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Synthes (USA) Products LLC
- FDA Inspection 1029323 - 2017-10-20
- FDA Inspection 1032557 - 2017-10-17
- FDA Inspection 1083832 - 2017-09-25
- FDA Inspection 695834 - 2010-10-29
- FDA Inspection 583439 - 2009-04-27
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