FDA Inspection
Skeletal Kinetics, LlcSkeletal Kinetics, Llc – FDA Inspection, Nov 13, 2009
Record Details
This FDA Inspection record concerns Skeletal Kinetics, Llc, with an inspection on November 13, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Skeletal Kinetics, Llc
- Inspection Date
- November 13, 2009
- Product Type
- Devices
View Company Profile
ID · 9c48e05f-fb78-4101-b47d-ca9ca98aa493
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 630687
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
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Other FDA inspections of Skeletal Kinetics, Llc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 5, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 23, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 9, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Skeletal Kinetics, Llc
- FDA Inspection 1067882 - 2018-10-05
- FDA Inspection 938737 - 2015-09-23
- FDA Inspection 786264 - 2012-07-09
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