FDA Inspection
CSL Plasma Inc.CSL Plasma Inc. – FDA Inspection, Nov 13, 2008
Record Details
This FDA Inspection record concerns CSL Plasma Inc., with an inspection on November 13, 2008, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- CSL Plasma Inc.
- Inspection Date
- November 13, 2008
- Product Type
- Biologics
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ID · 56b1eb61-344a-4786-83cb-e057ea9f6810
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 547210
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 606.171Biological product deviation report
- 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 |
|---|---|---|---|
| September 9, 2025 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 9, 2021 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| January 12, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 31, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 19, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for CSL Plasma Inc.
- FDA Inspection 1284264 - 2025-09-09
- FDA Inspection 1159651 - 2021-12-09
- FDA Inspection 999245 - 2017-01-12
- FDA Inspection 920456 - 2015-03-31
- FDA Inspection 820923 - 2013-03-19
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