FDA Inspection
CSL Plasma Inc.CSL Plasma Inc. – FDA Inspection, Jan 12, 2010
Record Details
This FDA Inspection record concerns CSL Plasma Inc., with an inspection on January 12, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- CSL Plasma Inc.
- Inspection Date
- January 12, 2010
- Product Type
- Biologics
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ID · 2341ad0f-4652-4232-b57e-5563a7d4cf58
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 643651
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 606.60(b)Equipment calibration frequency
- 21 CFR 606.171Biological product deviation report
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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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