FDA Inspection
Laerdal Medical A/SLaerdal Medical A/S – FDA Inspection, Jun 23, 2011
Record Details
This FDA Inspection record concerns Laerdal Medical A/S, with an inspection on June 23, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Laerdal Medical A/S
- Inspection Date
- June 23, 2011
- Product Type
- Devices
View Company Profile
ID · 9c44438c-0673-40ea-9f94-66d00428976b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 738432
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
Full citation text and observation details available on the Dashboard.
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 |
| August 22, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Laerdal Medical A/S
- FDA Inspection 994026 - 2016-11-10
- FDA Inspection 845097 - 2013-08-22
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