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FDA Inspection
•CSL Behring AG•April 13, 2018

CSL Behring AG – FDA Inspection, Apr 13, 2018

Record Details

This FDA Inspection record concerns CSL Behring AG, with an inspection on April 13, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
CSL Behring AG
Inspection Date
April 13, 2018
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
People
  • Cynthia Jim (FDA Associated Person)
  • Gene D. Arcy
View Company Profile

ID · f926487f-2e44-4432-98c7-9602dc241d81

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1057840
FDA center
Biologics
Project area
Blood and Blood Products
Outcome
Form 483 issued

Other FDA inspections of CSL Behring AG

5
DateClassificationOfficeProject area
February 18, 2020VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
September 29, 2016VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
June 19, 2014VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
February 2, 2012VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
January 19, 2010VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
Other documents for CSL Behring AG
  • FDA Inspection 1121637 - 2020-02-18
  • FDA Inspection 990288 - 2016-09-29
  • FDA Inspection 890258 - 2014-06-19
  • FDA Inspection 769044 - 2012-02-02
  • FDA Inspection 645082 - 2010-01-19

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