FDA Inspection
Gyrus Acmi, In.Gyrus Acmi, In. – FDA Inspection, Jun 21, 2018
Record Details
This FDA Inspection record concerns Gyrus Acmi, In., with an inspection on June 21, 2018, issued by the New England District Office, covering medical devices & rad health.
- Company
- Gyrus Acmi, In.
- Inspection Date
- June 21, 2018
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 06cc969b-8455-479e-92b5-9d42679d8f5d
Inspection Facts
- Inspection number
- 1094512
- FDA center
- Medical Devices & Rad Health
- Outcome
- Form 483 issued
Other FDA inspections of Gyrus Acmi, In.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 17, 2025 | Not classified | New England District Office | |
| June 11, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| 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 837099 - 2013-06-11
- FDA Inspection 668592 - 2010-06-24
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