FDA Inspection
CSL Plasma Inc.CSL Plasma Inc. – FDA Inspection, May 28, 2009
Record Details
This FDA Inspection record concerns CSL Plasma Inc., with an inspection on May 28, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- CSL Plasma Inc.
- Inspection Date
- May 28, 2009
- Product Type
- Biologics
View Company Profile
ID · ca31a223-5bbf-4dbc-a3c6-c18cdcaf12a9
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 587505
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
4- 21 CFR 640.65(b)(8)Timing
- 21 CFR 640.63(a)Determining donor suitability
- 21 CFR 640.65(b)(4)Amount of blood removed in a 48 Hr. period
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of CSL Plasma Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| December 4, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 14, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 12, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 2, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 22, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for CSL Plasma Inc.
- FDA Inspection 1256915 - 2024-12-04
- FDA Inspection 1034390 - 2017-11-14
- FDA Inspection 971388 - 2016-05-12
- FDA Inspection 872621 - 2014-04-02
- FDA Inspection 759702 - 2011-12-22
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