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CSL Behring GmbH, Hesse, Germany – FDA Inspections

Inspection records and compliance data for CSL Behring GmbH in Hesse, 35041. 8 FDA inspections on record, 4 Form 483s, 1 warning letter, last inspected February 18, 2026.

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Company Profile

This profile covers CSL Behring GmbH based in Hesse, 35041, Germany.

FDA Inspection History

FDA inspections
8
OAI
0
VAI
3
NAI
1
Unclassified
4
Form 483s
4
Warning letters
1

First inspected March 18, 2010. Last inspected February 18, 2026.

Most cited issue areas

  • Changes to Procedures Not Reviewed, Approved1 inspection
  • Cleaning / Sanitizing / Maintenance1 inspection
  • Lack of or inadequate procedures1 inspection

FDA inspections (8)

DateResultFDA center(s)Insp. #
February 18, 2026Not classifiedBiologics · Blood and Blood Products1298394
April 30, 2024Not classifiedHuman Drugs1242677
April 18, 2024Not classifiedMedical Devices & Rad Health · Compliance: Devices1231683
March 4, 2022VAIBiologics · Vaccines and Allergenic Products1166653
May 17, 2018Not classifiedBiologics1052244
May 17, 2016VAIBiologics · Blood and Blood Products1007037
January 27, 2012VAIBiologics · Blood and Blood Products786201
March 18, 2010NAIBiologics, Human Drugs · Vaccines and Allergenic Products655495
FDA documents

Form 483s (5)

  • Form 483s · February 18, 2026
  • Form 483s · April 30, 2024
  • Form 483s · April 18, 2024
  • Form 483s · March 4, 2022
  • Form 483s · May 17, 2018

Warning Letters (1)

  • Warning Letters

EIRs (1)

  • EIRs · March 4, 2022
People (3)
Prabhu P. Raju
Person
Debra M. Emerson
Person
Alexey Khrenov
Person
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Instituto Bioclon, S.A. de C.V.
The Abraham J. And Phyllis Katz Cord Blood
Grifols Therapeutics LLC
Sanofi Winthrop Industrie
Grifols Biologicals LLC
Company Information

Name

CSL Behring GmbH

FEI Number

3003098680

Address

Marburg, Hesse, 35041 Germany, Germany

Country

Germany

ID: 21a38e53-2e5d-4c9e-a287-79597f091cc6

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