FDA Inspection
CSL Plasma Inc.CSL Plasma Inc. – FDA Inspection, May 11, 2018
Record Details
This FDA Inspection record concerns CSL Plasma Inc., with an inspection on May 11, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · b956c8e7-ea9a-424c-83b1-3b609d4b824e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1051525
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 606.65(e)Following manufacturer"s instructions
- 21 CFR 606.65(e)Following manufacturer's instructions
Full citation text and observation details available on the Dashboard.
Other FDA inspections of CSL Plasma Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| December 31, 2025 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 19, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 9, 2011 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 27, 2009 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for CSL Plasma Inc.
- FDA Inspection 1297798 - 2025-12-31
- FDA Inspection 849991 - 2013-09-19
- FDA Inspection 741490 - 2011-08-09
- FDA Inspection 580389 - 2009-04-27
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