FDA Inspection
Skeletal Kinetics, LlcSkeletal Kinetics, Llc – FDA Inspection, Oct 5, 2018
Record Details
This FDA Inspection record concerns Skeletal Kinetics, Llc, with an inspection on October 5, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 8b363db7-75f2-46e8-b09c-8f45e41a45ab
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1067882
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
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Other FDA inspections of Skeletal Kinetics, Llc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 23, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 9, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 13, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Skeletal Kinetics, Llc
- FDA Inspection 938737 - 2015-09-23
- FDA Inspection 786264 - 2012-07-09
- FDA Inspection 630687 - 2009-11-13
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