FDA Inspection
CSL Plasma Inc.CSL Plasma Inc. – FDA Inspection, Jan 23, 2015
Record Details
This FDA Inspection record concerns CSL Plasma Inc., with an inspection on January 23, 2015, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- CSL Plasma Inc.
- Inspection Date
- January 23, 2015
- Product Type
- Biologics
View Company Profile
ID · 8ce74eb6-2c27-4a56-8d3a-b3546f94b843
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 913023
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
4- 21 CFR 606.100(c)Record review prior to release
- 21 CFR 630.40(b)(1)Deferred or not eligible
- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
Full citation text and observation details available on the Dashboard.
Other FDA inspections of CSL Plasma Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| April 7, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 25, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 25, 2013 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 8, 2011 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for CSL Plasma Inc.
- FDA Inspection 1204734 - 2023-04-07
- FDA Inspection 1034780 - 2017-10-25
- FDA Inspection 843959 - 2013-06-25
- FDA Inspection 756130 - 2011-11-08
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.