FDA Inspection
DT MedTech, LLCDT MedTech, LLC – FDA Inspection, Nov 8, 2016
Record Details
This FDA Inspection record concerns DT MedTech, LLC, with an inspection on November 8, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- People
- Erin L. Mcfiren (Issuing Officer)
- James M. Simpson (Company Rep)
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ID · 2d3da50b-012c-410a-bc11-413797d30f06
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 991573
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
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Other FDA inspections of DT MedTech, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 28, 2026 | Not classified | New Orleans District Office | Compliance: Devices |
| October 24, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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