FDA Inspection
CSL Plasma Inc.CSL Plasma Inc. – FDA Inspection, Jun 25, 2013
Record Details
This FDA Inspection record concerns CSL Plasma Inc., with an inspection on June 25, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- CSL Plasma Inc.
- Inspection Date
- June 25, 2013
- Product Type
- Biologics
View Company Profile
ID · a57a71b2-29d8-4cea-85a8-b8c60c40f470
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 843959
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 640.72(a)(3)Donor consent
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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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 |
| January 23, 2015 | 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 913023 - 2015-01-23
- FDA Inspection 756130 - 2011-11-08
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