FDA Inspection
Gambro Dasco SPA Monitors DivisionGambro Dasco SPA Monitors Division – FDA Inspection, Feb 12, 2009
Record Details
This FDA Inspection record concerns Gambro Dasco SPA Monitors Division, with an inspection on February 12, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- February 12, 2009
- Product Type
- Devices
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ID · d10278a6-20f1-46f6-b413-26d1ceacb59b
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 568943
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
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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 | |
| April 3, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 6, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Gambro Dasco SPA Monitors Division
- FDA Inspection 1328660 - 2026-07-16
- FDA Inspection 923510 - 2015-04-03
- FDA Inspection 667126 - 2010-05-06
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