FDA Inspection
Thuasne LLCThuasne LLC – FDA Inspection, Nov 9, 2018
Record Details
This FDA Inspection record concerns Thuasne LLC, with an inspection on November 9, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ff4474c9-1517-435e-81df-5a5f3f941d0d
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1071498
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.120(b)Labeling inspection - UDI
- 21 CFR 820.184DHR content
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
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Other FDA inspections of Thuasne LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 17, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 13, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 17, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Thuasne LLC
- FDA Inspection 850608 - 2013-09-17
- FDA Inspection 746415 - 2011-05-13
- FDA Inspection 682465 - 2010-03-17
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