FDA Inspection
CSL Plasma Inc.CSL Plasma Inc. – FDA Inspection, Aug 3, 2009
Record Details
This FDA Inspection record concerns CSL Plasma Inc., with an inspection on August 3, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- CSL Plasma Inc.
- Inspection Date
- August 3, 2009
- Product Type
- Biologics
View Company Profile
ID · 620c9632-eb4f-408e-b00b-a58174487c50
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 597716
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 640.63(a)Determination not made on day of collection
- 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.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 2, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 25, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 23, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for CSL Plasma Inc.
- FDA Inspection 1063243 - 2018-08-02
- FDA Inspection 876539 - 2014-04-25
- FDA Inspection 755571 - 2011-11-23
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