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•Switzerland

Cilag AG, Schaffhausen, Switzerland – FDA Inspections

Inspection records and compliance data for Cilag AG in Schaffhausen. 11 FDA inspections on record, 4 Form 483s, last inspected June 24, 2025.

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Company Profile

This profile covers Cilag AG based in Schaffhausen, Switzerland.

FDA Inspection History

FDA inspections
11
OAI
0
VAI
5
NAI
2
Unclassified
4
Form 483s
4
Warning letters
0

First inspected May 15, 2009. Last inspected June 24, 2025.

Most cited issue areas

  • Cleaning / Sanitizing / Maintenance1 inspection
  • Complete Test Data1 inspection
  • Establishment of time limitations1 inspection

FDA inspections (11)

DateResultFDA center(s)Insp. #
June 24, 2025Not classifiedHuman Drugs1279364
September 23, 2024Not classifiedHuman Drugs1257059
May 5, 2023NAIHuman Drugs · Drug Quality Assurance1208475
July 16, 2019VAIHuman Drugs · New Drug Evaluation1096373
December 8, 2017Not classifiedHuman Drugs1046091
May 19, 2017Not classifiedHuman Drugs, Medical Devices & Rad Health · Drug Quality Assurance1014940
September 8, 2015NAIHuman Drugs · Drug Quality Assurance940336
February 18, 2014VAIHuman Drugs · Drug Quality Assurance869788
April 27, 2012VAIHuman Drugs · Drug Quality Assurance788556
June 3, 2010VAIHuman Drugs · Drug Quality Assurance667864
May 15, 2009VAIHuman Drugs · Drug Quality Assurance582790
FDA documents

Form 483s (3)

  • Form 483s · June 16, 2025
  • Form 483s · September 23, 2024
  • Form 483s · July 16, 2019
People (4)
Santos E. Camara
Person
Thuy T. Nguyen
Person
Hyung-yul Lee
Person
Wayne E. Seifert
Person
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Company Information

Name

Cilag AG

FEI Number

3002806695

Address

Hochstrasse 201, Schaffhausen, Switzerland

Country

Switzerland

ID: acb7f670-89b9-4e40-a784-ed06b0282362

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