Company
FranceKoelis SAS, Meylan, France – FDA Inspections
Inspection records and compliance data for Koelis SAS in Meylan. 2 FDA inspections on record, 1 Form 483, last inspected July 26, 2018.
Company Profile
This profile covers Koelis SAS based in Meylan, France.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 0
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected June 3, 2015. Last inspected July 26, 2018.
Most cited issue areas
- Complaints1 inspection
- DHR content1 inspection
- Procedures for product review,disposition lack of/inadequate1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 26, 2018 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1060443 |
| June 3, 2015 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 932184 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Koelis SAS
FEI Number
3008487708
Address
16 Chemin Du Vieux Chene, Meylan, France
Country
France
ID: 8c879c96-a073-43c9-9e83-13ae7f5f5c4a