FDA Inspection
CSL Plasma, Inc.CSL Plasma, Inc. – FDA Inspection, Oct 26, 2017
Record Details
This FDA Inspection record concerns CSL Plasma, Inc., with an inspection on October 26, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 66ed5efe-9e1d-4f11-900a-b6688b48be20
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1029879
- 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.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| October 21, 2022 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 19, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 5, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 17, 2012 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 2, 2011 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for CSL Plasma, Inc.
- FDA Inspection 1182014 - 2022-10-21
- FDA Inspection 961840 - 2016-02-19
- FDA Inspection 868764 - 2014-03-05
- FDA Inspection 764129 - 2012-01-17
- FDA Inspection 744589 - 2011-09-02
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