FDA Inspection
CSL Plasma Inc.CSL Plasma Inc. – FDA Inspection, Sep 11, 2009
Record Details
This FDA Inspection record concerns CSL Plasma Inc., with an inspection on September 11, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- CSL Plasma Inc.
- Inspection Date
- September 11, 2009
- Product Type
- Biologics
View Company Profile
ID · 6088ae31-04c2-4e41-8779-3a323679cca1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 612590
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
1- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
Full citation text and observation details available on the Dashboard.
Other FDA inspections of CSL Plasma Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 22, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 30, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 16, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 28, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for CSL Plasma Inc.
- FDA Inspection 1217550 - 2023-08-22
- FDA Inspection 1023826 - 2017-06-30
- FDA Inspection 895963 - 2014-09-16
- FDA Inspection 738319 - 2011-07-28
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