Company
SwedenSwedish Orphan Biovitrum AB (Publ), Stockholm, Sweden – FDA Inspections
Inspection records and compliance data for Swedish Orphan Biovitrum AB (Publ) in Stockholm. 7 FDA inspections on record, 1 Form 483, last inspected August 29, 2019.
Company Profile
This profile covers Swedish Orphan Biovitrum AB (Publ) based in Stockholm, Sweden.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 5
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected January 20, 2009. Last inspected August 29, 2019.
Most cited issue areas
- Procedures to be written and followed1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 29, 2019 | NAI | Human Drugs · Bioresearch Monitoring | 1105180 |
| May 4, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1050664 |
| March 22, 2016 | VAI | Biologics · Blood and Blood Products | 965894 |
| May 1, 2014 | VAI | Biologics · Blood and Blood Products | 886772 |
| February 22, 2013 | NAI | Human Drugs · Drug Quality Assurance | 822730 |
| January 27, 2011 | VAI | Biologics, Human Drugs · Drug Quality Assurance | 725457 |
| January 20, 2009 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 569950 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Swedish Orphan Biovitrum AB (Publ)
FEI Number
3003455777
Address
Strandbergsgatan 49, Stockholm, Sweden
Country
Sweden
ID: ce015a15-5a97-47dd-9e01-2bd5eb4b40f7