FDA Inspection
Arch - MedTorque Inc.FDA Inspection 652628 - Arch - MedTorque Inc. - March 18, 2010
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Record Details
This FDA Inspection record concerns Arch - MedTorque Inc., with an inspection on March 18, 2010, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d182a3fa-b089-4fc9-9eaa-3bc79f56a7e9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 652628
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.198(a)General
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.20(c)Management review accomplishment
- 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Arch - MedTorque Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 15, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| 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 |