FDA Inspection
Ohmeda MedicalOhmeda Medical – FDA Inspection, Dec 8, 2016
Record Details
This FDA Inspection record concerns Ohmeda Medical, with an inspection on December 8, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Marc S. Neubauer (Issuing Officer)
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ID · ee539aa1-29d2-4b73-b45f-9ca8700314cf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 994404
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.30(g)Design validation - software validation not performed
- 21 CFR 820.70(i)Software validation for automated processes
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Other FDA inspections of Ohmeda Medical
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 19, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 6, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 18, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 24, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Ohmeda Medical
- FDA Inspection 929628 - 2015-06-19
- FDA Inspection 830289 - 2013-05-06
- FDA Inspection 787791 - 2012-06-18
- FDA Inspection 606986 - 2009-08-24
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