FDA Inspection
Draeger Medical Systems, Inc.Draeger Medical Systems, Inc. – FDA Inspection, Jul 9, 2009
Record Details
This FDA Inspection record concerns Draeger Medical Systems, Inc., with an inspection on July 9, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- July 9, 2009
- Product Type
- Devices
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ID · c9e4155a-b1af-4b35-9e8e-b6c961d6886b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 599345
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.100(a)(3)Identification of actions needed
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Other FDA inspections of Draeger Medical Systems, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 15, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 3, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 12, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Draeger Medical Systems, Inc.
- FDA Inspection 1180171 - 2022-08-15
- FDA Inspection 841183 - 2013-07-03
- FDA Inspection 562521 - 2009-02-12
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