FDA Inspection
Arch - MedTorque Inc.FDA Inspection 1225420 - Arch - MedTorque Inc. - December 15, 2023
Record Details
This FDA Inspection record concerns Arch - MedTorque Inc., with an inspection on December 15, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 129648da-bef8-4583-a292-2b0651495051
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1225420
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.100(b)Documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
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Other FDA inspections of Arch - MedTorque Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 15, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 20, 2014 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 18, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Arch - MedTorque Inc.
- FDA Inspection 1054772 - 2018-05-15
- FDA Inspection 870654 - 2014-03-20
- FDA Inspection 652628 - 2010-03-18
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