FDA Inspection
CSL Plasma Inc.CSL Plasma Inc. – FDA Inspection, Jan 9, 2015
Record Details
This FDA Inspection record concerns CSL Plasma Inc., with an inspection on January 9, 2015, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- CSL Plasma Inc.
- Inspection Date
- January 9, 2015
- Product Type
- Biologics
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ID · 6eaad0bf-fad9-4e9e-8439-5a0aee052fa0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 909511
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 640.63(d)Unreliable answers
- 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 |
|---|---|---|---|
| April 21, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 8, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 18, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for CSL Plasma Inc.
- FDA Inspection 1204362 - 2023-04-21
- FDA Inspection 1111591 - 2019-11-08
- FDA Inspection 1029973 - 2017-10-18
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