FDA Inspection
Tegra Medical Costa Rica SaTegra Medical Costa Rica Sa – FDA Inspection, Jun 29, 2023
Record Details
This FDA Inspection record concerns Tegra Medical Costa Rica Sa, with an inspection on June 29, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 31aef1d6-104f-4898-b149-d777ebe5294a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1209330
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of Tegra Medical Costa Rica Sa
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 4, 2025 | Not classified | Office of Inspections and Investigations | |
| May 18, 2017 | Not classified | Office of Inspections and Investigations | Postmarket Assurance: Devices |
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