Company
SwedenAurena Laboratories AB, Karlstad, Sweden – FDA Inspections
Inspection records and compliance data for Aurena Laboratories AB in Karlstad. 2 FDA inspections on record, 1 Form 483, last inspected September 13, 2019.
Company Profile
This profile covers Aurena Laboratories AB based in Karlstad, Sweden.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected June 1, 2016. Last inspected September 13, 2019.
Most cited issue areas
- Complete test data included in records1 inspection
- Investigations of discrepancies, failures1 inspection
- Representative Samples1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 13, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1101986 |
| June 1, 2016 | VAI | Human Drugs · Drug Quality Assurance | 972344 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Aurena Laboratories AB
FEI Number
3004080052
Address
Fjarrviksvagen 22, Karlstad, Sweden
Country
Sweden
ID: a2b929af-52f9-4562-a6c3-9a027352b562