FDA Inspection
Octapharma ABOctapharma AB – FDA Inspection, Sep 19, 2023
Record Details
This FDA Inspection record concerns Octapharma AB, with an inspection on September 19, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 3645f477-d675-40fc-90b8-3704a595408d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1218250
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.110(a)Written in-process control procedures
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.110(a)Written in-process control procedures
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
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Other FDA inspections of Octapharma AB
6| Date | Classification | Office | Project area |
|---|---|---|---|
| September 28, 2018 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 3, 2016 | Not classified | Office of Inspections and Investigations | |
| April 28, 2014 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 19, 2012 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 20, 2011 | OAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Octapharma AB
- FDA Inspection 1070173 - 2018-09-28
- FDA Inspection 994537 - 2016-10-03
- FDA Inspection 894095 - 2014-04-28
- FDA Inspection 783783 - 2012-01-19
- FDA Inspection 710676 - 2011-01-20
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