FDA Inspection
Gyrus Acmi, In.Gyrus Acmi, In. – FDA Inspection, Jun 11, 2013
Record Details
This FDA Inspection record concerns Gyrus Acmi, In., with an inspection on June 11, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Gyrus Acmi, In.
- Inspection Date
- June 11, 2013
- Product Type
- Devices
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ID · bf2344e6-6053-4ea2-b131-848d165429a9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 837099
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Gyrus Acmi, In.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 17, 2025 | Not classified | New England District Office | |
| June 21, 2018 | Not classified | New England District Office | |
| June 24, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Gyrus Acmi, In.
- FDA Inspection 1294514 - 2025-10-17
- FDA Inspection 1094512 - 2018-06-21
- FDA Inspection 668592 - 2010-06-24
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