FDA Inspection
Captiva Spine, IncCaptiva Spine, Inc – FDA Inspection, Feb 17, 2017
Record Details
This FDA Inspection record concerns Captiva Spine, Inc, with an inspection on February 17, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d8e3c779-63c7-457c-924b-3379c9dba0e9
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1005162
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 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 Captiva Spine, Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| February 13, 2025 | Not classified | Florida District Office | |
| January 14, 2025 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 14, 2019 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| January 16, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 9, 2012 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Captiva Spine, Inc
- FDA Inspection 1262246 - 2025-02-13
- FDA Inspection 1258846 - 2025-01-14
- FDA Inspection 1093472 - 2019-05-14
- FDA Inspection 815376 - 2013-01-16
- FDA Inspection 771991 - 2012-03-09
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