FDA Inspection
Swedish Orphan Biovitrum AB (Publ)Swedish Orphan Biovitrum AB (Publ) – FDA Inspection, May 4, 2018
Record Details
This FDA Inspection record concerns Swedish Orphan Biovitrum AB (Publ), with an inspection on May 4, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · fedd8529-51b4-48a4-a3ce-9099fcb8a7d3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1050664
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.198(a)Procedures to be written and followed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Swedish Orphan Biovitrum AB (Publ)
6| Date | Classification | Office | Project area |
|---|---|---|---|
| August 29, 2019 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| March 22, 2016 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 1, 2014 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 22, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 27, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Swedish Orphan Biovitrum AB (Publ)
- FDA Inspection 1105180 - 2019-08-29
- FDA Inspection 965894 - 2016-03-22
- FDA Inspection 886772 - 2014-05-01
- FDA Inspection 822730 - 2013-02-22
- FDA Inspection 725457 - 2011-01-27
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