FDA Inspection
SedatelecSedatelec – FDA Inspection, Sep 27, 2012
Record Details
This FDA Inspection record concerns Sedatelec, with an inspection on September 27, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Sedatelec
- Inspection Date
- September 27, 2012
- Product Type
- Devices
View Company Profile
ID · 8e918ee0-3c0f-4a72-bf36-d8b6afd21d3a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 803691
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.50(b)Supplier notification of changes
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Sedatelec
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 27, 2017 | Not classified | Office of Inspections and Investigations | |
| January 15, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 17, 2008 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Sedatelec
- FDA Inspection 1052129 - 2017-11-27
- FDA Inspection 912065 - 2015-01-15
- FDA Inspection 547246 - 2008-10-17
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