FDA Inspection
CSL Plasma Inc.CSL Plasma Inc. – FDA Inspection, Dec 8, 2009
Record Details
This FDA Inspection record concerns CSL Plasma Inc., with an inspection on December 8, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- CSL Plasma Inc.
- Inspection Date
- December 8, 2009
- Product Type
- Biologics
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ID · eff08a91-2157-483f-9019-1cbfefd9cb85
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 634606
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
4- 21 CFR 640.65(b)(3)Donor identification system
- 21 CFR 606.100(c)Thorough investigations
- 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.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 21, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 14, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 14, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 26, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for CSL Plasma Inc.
- FDA Inspection 1232706 - 2024-03-21
- FDA Inspection 1071041 - 2018-09-14
- FDA Inspection 985193 - 2016-06-14
- FDA Inspection 898360 - 2014-09-26
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