FDA Inspection 1330840 — Nitinol Devices And Components Costa Rica, S.R.L.
The FDA completed an inspection of Nitinol Devices And Components Costa Rica, S.R.L. on Aug 13, 2026 in El Coyol. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 13, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- El Coyol (Costa Rica)
Citations
| ID | CFR | Description |
|---|---|---|
| 23072 | ISO 13485:2016 Clause 6.2(b) | Personnel training not provided |
| 23258 | ISO 13485:2016 Clause 8.5.2 | Corrective action procedures not documented |