FDA Inspection
Gambro Dasco SPA Monitors DivisionGambro Dasco SPA Monitors Division – FDA Inspection, Apr 3, 2015
Record Details
This FDA Inspection record concerns Gambro Dasco SPA Monitors Division, with an inspection on April 3, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- April 3, 2015
- Product Type
- Devices
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ID · c5968372-0a2e-49d7-bd49-be456a094647
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 923510
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of Gambro Dasco SPA Monitors Division
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 16, 2026 | Not classified | Office of Inspections and Investigations | |
| May 6, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 12, 2009 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Gambro Dasco SPA Monitors Division
- FDA Inspection 1328660 - 2026-07-16
- FDA Inspection 667126 - 2010-05-06
- FDA Inspection 568943 - 2009-02-12
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