FDA Inspection
Gyrus ACMI, Inc.Gyrus ACMI, Inc. – FDA Inspection, Sep 18, 2013
Record Details
This FDA Inspection record concerns Gyrus ACMI, Inc., with an inspection on September 18, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Gyrus ACMI, Inc.
- Inspection Date
- September 18, 2013
- Product Type
- Devices
View Company Profile
ID · c3e19e26-8fbd-4c81-94e1-d4e867e40ca0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 848969
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.100(b)Documentation
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.30(g)Design validation - documentation
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Other FDA inspections of Gyrus ACMI, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 2, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 1, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 15, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Gyrus ACMI, Inc.
- FDA Inspection 1170310 - 2022-05-02
- FDA Inspection 977394 - 2016-07-01
- FDA Inspection 683599 - 2010-09-15
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