FDA Inspection
Unified Spine, LlcUnified Spine, Llc – FDA Inspection, Nov 18, 2011
Record Details
This FDA Inspection record concerns Unified Spine, Llc, with an inspection on November 18, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Unified Spine, Llc
- Inspection Date
- November 18, 2011
- Product Type
- Devices
View Company Profile
ID · ea943dc2-6a25-4e77-ab06-251eb16789a9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 754612
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.170(b)Installer records
- 21 CFR 820.50(b)Supplier notification of changes
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Other FDA inspections of Unified Spine, Llc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 1, 2024 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 4, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 6, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 23, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Unified Spine, Llc
- FDA Inspection 1233724 - 2024-03-01
- FDA Inspection 1114511 - 2019-12-04
- FDA Inspection 1020853 - 2017-07-06
- FDA Inspection 983542 - 2016-08-23
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