FDA Inspection
Thinklabs Medical LLCThinklabs Medical LLC – FDA Inspection, Oct 30, 2017
Record Details
This FDA Inspection record concerns Thinklabs Medical LLC, with an inspection on October 30, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f31a8369-0653-4c19-a215-d14afa144a54
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1030348
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.80(e)Documentation
- 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
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Other FDA inspections of Thinklabs Medical LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 29, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 16, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Thinklabs Medical LLC
- FDA Inspection 889645 - 2014-07-29
- FDA Inspection 703181 - 2010-12-16
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