FDA Inspection
Gyrus ACMI, Inc.Gyrus ACMI, Inc. – FDA Inspection, Apr 17, 2018
Record Details
This FDA Inspection record concerns Gyrus ACMI, Inc., with an inspection on April 17, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 30c7858f-52e3-435b-a5ed-183917e0df20
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1048537
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 812.40Sponsors" general responsibilities
- 21 CFR 812.40Sponsors' general responsibilities
Full citation text and observation details available on the Dashboard.
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 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 14, 2012 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| 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 920803 - 2015-04-03
- FDA Inspection 840684 - 2013-06-21
- FDA Inspection 789809 - 2012-06-14
- FDA Inspection 731008 - 2011-06-13
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