FDA Inspection
Calvary Spine, LLCCalvary Spine, LLC – FDA Inspection, Jan 25, 2018
Record Details
This FDA Inspection record concerns Calvary Spine, LLC, with an inspection on January 25, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · bf8344f8-7893-4f04-8649-a750095f4966
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1039010
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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Other FDA inspections of Calvary Spine, LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| May 2, 2025 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 29, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 21, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 11, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Calvary Spine, LLC
- FDA Inspection 1269031 - 2025-05-02
- FDA Inspection 971034 - 2016-01-29
- FDA Inspection 823500 - 2013-03-21
- FDA Inspection 651527 - 2010-03-11
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