FDA Inspection
Adroit Medical Systems IncAdroit Medical Systems Inc – FDA Inspection, Apr 11, 2019
Record Details
This FDA Inspection record concerns Adroit Medical Systems Inc, with an inspection on April 11, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 4aac48a8-eef6-43d8-ae94-4ab3b15084fc
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1085944
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.72(b)Remedial action - documentation
- 21 CFR 820.80(c)Documentation
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Other FDA inspections of Adroit Medical Systems Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 11, 2025 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 12, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 23, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 28, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Adroit Medical Systems Inc
- FDA Inspection 1278307 - 2025-07-11
- FDA Inspection 1017646 - 2017-07-12
- FDA Inspection 765950 - 2012-01-23
- FDA Inspection 642668 - 2010-01-28
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