FDA Inspection
DT MedTech, LLCDT MedTech, LLC – FDA Inspection, Oct 24, 2017
Record Details
This FDA Inspection record concerns DT MedTech, LLC, with an inspection on October 24, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- People
- Daniel R. Tammariello (Issuing Officer)
- James M. Simpson (Company Rep)
- Katelyn A. Staub-Zamperini (Issuing Officer)
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ID · fb9f2a0f-4dd2-4bf0-80c1-ecdb41584381
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1029760
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
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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 |
| November 8, 2016 | OAI | Center for Devices and Radiological Health | Project Evaluation: Devices |
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