FDA Inspection
Nexxt Spine, LLCNexxt Spine, LLC – FDA Inspection, Dec 30, 2016
Record Details
This FDA Inspection record concerns Nexxt Spine, LLC, with an inspection on December 30, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
View Company Profile
ID · 76688b96-9d61-4902-92f4-f782945937dd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 997755
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 1271.265(e)Procedures and release criteria
- 21 CFR 1271.160(b)(4)Training of personnel
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Nexxt Spine, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 11, 2025 | NAI | Detroit District Office | Postmarket Assurance: Medical Devices |
| April 27, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Nexxt Spine, LLC
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.