FDA Inspection
Gyrus ACMI, Inc.Gyrus ACMI, Inc. – FDA Inspection, Jun 14, 2012
Record Details
This FDA Inspection record concerns Gyrus ACMI, Inc., with an inspection on June 14, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Gyrus ACMI, Inc.
- Inspection Date
- June 14, 2012
- Product Type
- Devices
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ID · 1f770ace-4963-43eb-90dc-ff61e9676223
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 789809
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 812.43(c)No investigator agreement
- 21 CFR 812.40Sponsors" general responsibilities
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Other FDA inspections of Gyrus ACMI, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| May 23, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 17, 2018 | VAI | Center for Devices and Radiological Health | Project Evaluation: Devices |
| April 3, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 21, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 13, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Gyrus ACMI, Inc.
- FDA Inspection 1055329 - 2018-05-23
- FDA Inspection 1048537 - 2018-04-17
- FDA Inspection 920803 - 2015-04-03
- FDA Inspection 840684 - 2013-06-21
- FDA Inspection 731008 - 2011-06-13
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