FDA Inspection
CSL Plasma Inc.CSL Plasma Inc. – FDA Inspection, Aug 14, 2009
Record Details
This FDA Inspection record concerns CSL Plasma Inc., with an inspection on August 14, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- CSL Plasma Inc.
- Inspection Date
- August 14, 2009
- Product Type
- Biologics
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ID · 5aca8a42-ebdf-4790-97fc-0bd17cf4becb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 605487
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 211.186(a)Written procedures followed
- 21 CFR 606.170(a)Adverse Reaction- Reports of Investigations
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of CSL Plasma Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| August 4, 2021 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| June 16, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 13, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 15, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 15, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for CSL Plasma Inc.
- FDA Inspection 1150540 - 2021-08-04
- FDA Inspection 1018616 - 2017-06-16
- FDA Inspection 915471 - 2015-02-13
- FDA Inspection 822927 - 2013-03-15
- FDA Inspection 745538 - 2011-09-15
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