FDA Inspection
Unified Spine, LlcUnified Spine, Llc – FDA Inspection, Mar 1, 2024
Record Details
This FDA Inspection record concerns Unified Spine, Llc, with an inspection on March 1, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · c81596e8-5137-4886-93ee-2e06b3bc84ed
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1233724
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Unified Spine, Llc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| November 18, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Unified Spine, Llc
- FDA Inspection 1114511 - 2019-12-04
- FDA Inspection 1020853 - 2017-07-06
- FDA Inspection 983542 - 2016-08-23
- FDA Inspection 754612 - 2011-11-18
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