FDA Inspection
Laerdal Medical A/SLaerdal Medical A/S – FDA Inspection, Aug 22, 2013
Record Details
This FDA Inspection record concerns Laerdal Medical A/S, with an inspection on August 22, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Laerdal Medical A/S
- Inspection Date
- August 22, 2013
- Product Type
- Devices
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ID · 62d0a5e3-ce64-4842-8ba6-9895b8356235
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 845097
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.70(a)Production processes
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Other FDA inspections of Laerdal Medical A/S
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 10, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 23, 2011 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Laerdal Medical A/S
- FDA Inspection 994026 - 2016-11-10
- FDA Inspection 738432 - 2011-06-23
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