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FDA Inspection
•CSL Plasma Inc.•February 20, 2013

CSL Plasma Inc. – FDA Inspection, Feb 20, 2013

Record Details

This FDA Inspection record concerns CSL Plasma Inc., with an inspection on February 20, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
CSL Plasma Inc.
Inspection Date
February 20, 2013
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · 692291ae-2437-4ff2-b5c1-5bcfa87d8d9c

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
819182
FDA center
Biologics
Project area
Blood and Blood Products

FDA Citations

1
  1. 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.

5
DateClassificationOfficeProject area
December 16, 2022NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
November 21, 2018NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
September 11, 2015NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
November 15, 2010NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
January 13, 2009NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
Other documents for CSL Plasma Inc.
  • FDA Inspection 1194612 - 2022-12-16
  • FDA Inspection 1074767 - 2018-11-21
  • FDA Inspection 944254 - 2015-09-11
  • FDA Inspection 697816 - 2010-11-15
  • FDA Inspection 555841 - 2009-01-13

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