FDA Inspection
Facet Technologies, LLCFDA Inspection 969383 - Facet Technologies, LLC - May 03, 2016
Record Details
This FDA Inspection record concerns Facet Technologies, LLC, with an inspection on May 3, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Facet Technologies, LLC
- Inspection Date
- May 3, 2016
- Product Type
- Devices
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ID · 41717fa2-1472-4ed3-ac93-4f09a423f115
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 969383
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.198(a)Complaints
- 21 CFR 803.17(b)(2)Reports and information documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Facet Technologies, LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| April 28, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 25, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 8, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 30, 2011 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 7, 2009 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Facet Technologies, LLC
- FDA Inspection 968354 - 2016-04-28
- FDA Inspection 850600 - 2013-09-25
- FDA Inspection 745517 - 2011-09-08
- FDA Inspection 717516 - 2011-03-30
- FDA Inspection 585780 - 2009-04-07
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