FDA Inspection
Adroit Medical Systems IncAdroit Medical Systems Inc – FDA Inspection, Jul 12, 2017
Record Details
This FDA Inspection record concerns Adroit Medical Systems Inc, with an inspection on July 12, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Matthew R. Mcnew (Issuing Officer)
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ID · 0a49925c-d027-450a-a454-1bba0f57c991
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1017646
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.184DHR content
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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 |
| April 11, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: 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 1085944 - 2019-04-11
- FDA Inspection 765950 - 2012-01-23
- FDA Inspection 642668 - 2010-01-28
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