FDA Inspection
Tegra Medical Costa Rica SaTegra Medical Costa Rica Sa – FDA Inspection, May 18, 2017
Record Details
This FDA Inspection record concerns Tegra Medical Costa Rica Sa, with an inspection on May 18, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Company
- Tegra Medical Costa Rica Sa
- Inspection Date
- May 18, 2017
- Product Type
- Medical Devices & Rad Health
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ID · a0b1c6fa-5e41-40eb-a272-568b2b05e53a
Inspection Facts
- Inspection number
- 1022549
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(g)(2)Periodic equipment inspection lack of or inadequate procedu
- 21 CFR 820.75(a)Lack of or inadequate process validation
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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 | |
| June 29, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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