FDA Inspection
Laerdal Medical (Suzhou) Co., Ltd.Laerdal Medical (Suzhou) Co., Ltd. – FDA Inspection, Jun 6, 2013
Record Details
This FDA Inspection record concerns Laerdal Medical (Suzhou) Co., Ltd., with an inspection on June 6, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- June 6, 2013
- Product Type
- Devices
View Company Profile
ID · d3f60d62-da7b-4b33-9bea-c50f5a50d592
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 838796
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.75(a)Documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Laerdal Medical (Suzhou) Co., Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 3, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 28, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Laerdal Medical (Suzhou) Co., Ltd.
- FDA Inspection 1029850 - 2016-11-03
- FDA Inspection 660424 - 2010-04-28
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.