FDA Inspection
Spineguard, SaSpineguard, Sa – FDA Inspection, Sep 10, 2026
Record Details
This FDA Inspection record concerns Spineguard, Sa, with an inspection on September 10, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · f24dd4ac-ccc9-49cf-b5bc-dac0bd5cc088
Inspection Facts
- Inspection number
- 1335054
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- ISO 13485:2016 Clause 7.1Records of risk management activities in product realization not maintained
- ISO 13485:2016 Clause 7.3.9Requirements for design and development changes not met before implementation
- ISO 13485:2016 Clause 8.5.2Corrective action not taken
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Other FDA inspections of Spineguard, Sa
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 29, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Spineguard, Sa
- FDA Inspection 1051187 - 2018-03-29
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