Atlas

FDA-Inspected Site

Cilag AG

16 FDA inspections are on record for Cilag AG in Schaffhausen, Switzerland.

483· Form 483 issued

Schaffhausen, Switzerland · Last updated August 15, 2026

Overview

  • 16 FDA inspections are on record.
  • 9 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-06-24.

At a glance

Inspections

16

Form 483s

9

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
16 Jun 2025 – 24 Jun 2025Human Drugs483On file
17 Sep 2024 – 23 Sep 2024Human Drugs483On file
24 Apr 2023 – 5 May 2023Human DrugsClean
4 Nov 2019 – 8 Nov 2019Human DrugsClean
8 Jul 2019 – 16 Jul 2019Human Drugs483View 483 →
4 Dec 2017 – 8 Dec 2017Human DrugsClean
11 May 2017 – 19 May 2017Medical Devices & Rad Health483View 483 →
4 Apr 2016 – 8 Apr 2016Human DrugsClean
31 Aug 2015 – 8 Sep 2015Human DrugsClean
17 Feb 2014 – 18 Feb 2014Human Drugs483View 483 →
27 Apr 2012Not recorded483On file
29 Jul 2011Not recorded483On file

Observations on record

Form 483 observations cited at this site, most recent first.

16 Jul 2019
21 CFR 211.160(a)

Following/documenting laboratory controls

Cited by Santos E Camara

16 Jul 2019
21 CFR 211.160(a)

Following/documenting laboratory controls

Cited by Santos E Camara

16 Jul 2019
21 CFR 211.194(a)(4)

Complete Test Data

Cited by Santos E Camara

16 Jul 2019
21 CFR 211.194(a)(4)

Complete Test Data

Cited by Santos E Camara

16 Jul 2019
21 CFR 211.194(d)

Laboratory equipment calibration records

Cited by Santos E Camara

Investigators

FDA investigators tied to this site in the record.

Wayne E Seifert1 insp.
Thuy T Nguyen1 insp.
Cassandra L Abellard1 insp.
Hyung-Yul Lee1 insp.
Alice S Tsao1 insp.
Tonia F Bernard1 insp.
Santos E Camara1 insp.
Laura Fontan1 insp.
Ademola O Daramola1 insp.
Don H Bark1 insp.
Zhongren Wu1 insp.
Joshua P Wireman1 insp.
Zachary A Bogorad1 insp.
Jose A Cruz Gonzalez1 insp.
Christian Lynch1 insp.
Anthony F Lorenzo1 insp.
Jennifer L Schmidt1 insp.
Omotunde O Osunsanmi1 insp.
Mihaly S Ligmond1 insp.
Rose M Ashley1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.113(b)Cited across public-safe Form 483 observations3x
21 CFR 211.22(d)Cited across public-safe Form 483 observations3x
21 CFR 211.67(a)Cited across public-safe Form 483 observations3x
21 CFR 211.111Cited across public-safe Form 483 observations2x
21 CFR 211.160(a)Cited across public-safe Form 483 observations2x
21 CFR 211.160(b)Cited across public-safe Form 483 observations2x
21 CFR 211.192Cited across public-safe Form 483 observations2x
21 CFR 211.194(a)(4)Cited across public-safe Form 483 observations2x
21 CFR 211.194(d)Cited across public-safe Form 483 observations2x
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.198(a)Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x
21 CFR 211.56(b)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Cilag AG's 9 Form 483s

Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat