FDA Inspection
Thuasne LLCThuasne LLC – FDA Inspection, Mar 17, 2010
Record Details
This FDA Inspection record concerns Thuasne LLC, with an inspection on March 17, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Thuasne LLC
- Inspection Date
- March 17, 2010
- Product Type
- Devices
View Company Profile
ID · 9a85535f-6f91-4c19-96b8-8f153ffa9d95
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 682465
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
11- 21 CFR 820.198(a)General
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.120(d)Records, DHR {see also 820.184(e)}
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.60Identification procedures, Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.181(a)DMR device specifications
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Other FDA inspections of Thuasne LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 9, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 17, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 13, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Thuasne LLC
- FDA Inspection 1071498 - 2018-11-09
- FDA Inspection 850608 - 2013-09-17
- FDA Inspection 746415 - 2011-05-13
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