FDA Inspection
SPITREX ORTHOPEDICS SWITZERLAND SASPITREX ORTHOPEDICS SWITZERLAND SA – FDA Inspection, May 7, 2026
Record Details
This FDA Inspection record concerns SPITREX ORTHOPEDICS SWITZERLAND SA, with an inspection on May 7, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- May 7, 2026
- Product Type
- Medical Devices & Rad Health
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ID · 318b049a-2be8-44cb-9215-cd62b54e192a
Inspection Facts
- Inspection number
- 1315874
- 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 8.2.2Complaint handling procedures not documented
- ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
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Other FDA inspections of SPITREX ORTHOPEDICS SWITZERLAND SA
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 27, 2017 | Not classified | Office of Inspections and Investigations |
Other documents for SPITREX ORTHOPEDICS SWITZERLAND SA
- FDA Inspection 1004999 - 2017-01-27
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