Company
FranceSedatelec, Irigny, France – FDA Inspections
Inspection records and compliance data for Sedatelec in Irigny. 4 FDA inspections on record, 1 Form 483, last inspected November 27, 2017.
Company Profile
This profile covers Sedatelec based in Irigny, France.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected October 17, 2008. Last inspected November 27, 2017.
Most cited issue areas
- Supplier notification of changes1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 27, 2017 | Not classified | Medical Devices & Rad Health | 1052129 |
| January 15, 2015 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 912065 |
| September 27, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 803691 |
| October 17, 2008 | VAI | Medical Devices & Rad Health · Compliance: Devices | 547246 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Sedatelec
FEI Number
5711
Address
5 Chemin Des Muriers, Irigny, France
Country
France
ID: 745fa75a-b7e5-4d2f-8dc2-d44233eeb3f3