FDA Inspection
NuTech Spine, Inc.NuTech Spine, Inc. – FDA Inspection, Jun 20, 2019
Record Details
This FDA Inspection record concerns NuTech Spine, Inc., with an inspection on June 20, 2019, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Wendy R. Blame (Issuing Officer)
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ID · 95477789-df9a-42ca-9226-3a7b1e415c8a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1094097
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.100(a)Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of NuTech Spine, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| October 27, 2021 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| April 25, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 13, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 18, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 30, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for NuTech Spine, Inc.
- FDA Inspection 1155920 - 2021-10-27
- FDA Inspection 1056306 - 2018-04-25
- FDA Inspection 982009 - 2016-07-13
- FDA Inspection 884316 - 2014-06-18
- FDA Inspection 833696 - 2013-04-30
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