FDA Inspection
TIATIA – FDA Inspection, Feb 11, 2026
Record Details
This FDA Inspection record concerns TIA, with an inspection on February 11, 2026, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 9ec07d3a-1c20-477b-9006-f639ad79a9ae
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1302350
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 801.20(a)Label to bear a unique device identifier
- ISO 13485:2016 Clause 4.1.2Risk-based approach not applied to QMS processes
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of TIA
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 9, 2026 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| July 15, 2025 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| February 21, 2025 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| November 16, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for TIA
- FDA Inspection 1306798 - 2026-03-09
- FDA Inspection 1277479 - 2025-07-15
- FDA Inspection 1262952 - 2025-02-21
- FDA Inspection 1224865 - 2023-11-16
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