FDA Inspection
Nitinol Devices and Components Costa Rica, S.R.L.Nitinol Devices and Components Costa Rica, S.R.L. – FDA Inspection, Aug 13, 2026
Record Details
This FDA Inspection record concerns Nitinol Devices and Components Costa Rica, S.R.L., with an inspection on August 13, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- August 13, 2026
- Product Type
- Medical Devices & Rad Health
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ID · 9e7849c2-ac50-41b6-9dfa-f7778b2738e5
Inspection Facts
- Inspection number
- 1330840
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
2- ISO 13485:2016 Clause 6.2(b)Personnel training not provided
- ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
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Other FDA inspections of Nitinol Devices and Components Costa Rica, S.R.L.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 12, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Nitinol Devices and Components Costa Rica, S.R.L.
- FDA Inspection 972428 - 2016-05-12
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