FDA Inspection
DT MedTech, LLCDT MedTech, LLC – FDA Inspection, May 28, 2026
Record Details
This FDA Inspection record concerns DT MedTech, LLC, with an inspection on May 28, 2026, issued by the New Orleans District Office, covering medical devices & rad health.
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ID · 55ff8cbc-d25d-4d9a-8a44-aae5212d11c6
Inspection Facts
- Inspection number
- 1319492
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- ISO 13485:2016 Clause 7.3.3Design and development inputs incomplete or inadequate
- ISO 13485:2016 Clause 8.2.1Information gathered in feedback process not used as input into risk management
- ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
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Other FDA inspections of DT MedTech, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 24, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 8, 2016 | OAI | Center for Devices and Radiological Health | Project Evaluation: Devices |
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