FDA Inspection
Spineology, Inc.Spineology, Inc. – FDA Inspection, Mar 31, 2017
Record Details
This FDA Inspection record concerns Spineology, Inc., with an inspection on March 31, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e2314acc-1781-4390-addd-06284914dd84
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1012390
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.150Lack of or inadequate procedures for storage.
- 21 CFR 820.184DHR content
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.90(a)Nonconforming product control
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Spineology, Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| June 17, 2025 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| April 17, 2025 | NAI | Minneapolis District Office | Postmarket Assurance: Medical Devices |
| February 15, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 12, 2018 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| December 5, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Spineology, Inc.
- FDA Inspection 1275322 - 2025-06-17
- FDA Inspection 1267116 - 2025-04-17
- FDA Inspection 1162392 - 2022-02-15
- FDA Inspection 1071565 - 2018-10-12
- FDA Inspection 995031 - 2016-12-05
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