Atlas

FDA-Inspected Site

F. Hoffmann-La Roche AG

13 FDA inspections are on record for F. Hoffmann-La Roche AG in Kaiseraugst, Switzerland.

483· Form 483 issued

Kaiseraugst, Switzerland · Last updated July 10, 2026

Overview

  • 13 FDA inspections are on record.
  • 8 inspections produced a Form 483.
  • The most recent recorded inspection date is 2024-11-04.

At a glance

Inspections

13

Form 483s

8

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
28 Oct 2024 – 4 Nov 2024Human Drugs483On file
28 Jul 2022 – 5 Aug 2022Human Drugs483View 483 →
11 Jan 2021 – 15 Jan 2021Human DrugsClean
26 Apr 2018 – 4 May 2018Human Drugs483View 483 →
5 Sep 2016 – 13 Sep 2016Human Drugs483View 483 →
21 Jan 2016Human DrugsClean
1 Dec 2014 – 9 Dec 2014Human Drugs483On file
31 Mar 2014 – 8 Apr 2014Human Drugs483View 483 →
22 Jul 2013 – 25 Jul 2013Medical Devices & Rad Health483View 483 →
9 Mar 2012Not recordedClean
29 Jul 2011Not recordedClean
2 Jul 2009Not recorded483View 483 →

Observations on record

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

5 Aug 2022
21 CFR 211.192

Written record of investigation incomplete

Cited by Michael A Charles

5 Aug 2022
21 CFR 211.42(c)(10)(iv)

Environmental Monitoring System

Cited by Michael A Charles

5 Aug 2022
21 CFR 211.46(b)

Equipment for Environmental Control

Cited by Michael A Charles

4 May 2018
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Anita Narula, Michael E Maselli

4 May 2018
21 CFR 600.14(c)

When to report

Cited by Anita Narula, Michael E Maselli

Investigators

FDA investigators tied to this site in the record.

Reyes Candau-Chacon2 insp.
Liqun Zhao1 insp.
Michael A Charles1 insp.
Teresa I Navas1 insp.
Anita Narula1 insp.
Michael E Maselli1 insp.
Samina S Khan1 insp.
Arsen Karapetyan1 insp.
Zhihao Pete Qiu1 insp.
Stephen D Brown1 insp.
Benjamin J Dastoli1 insp.
Steven Fong1 insp.
Brenda W Uratani1 insp.
Andrea A Branche1 insp.
Torrance J Slayton1 insp.
Tina M Pawlowski1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations4x
21 CFR 211.80(a)Cited across public-safe Form 483 observations2x
21 CFR 211.113(b)Cited across public-safe Form 483 observations1x
21 CFR 211.122(a)Cited across public-safe Form 483 observations1x
21 CFR 211.125(a)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(10)(iv)Cited across public-safe Form 483 observations1x
21 CFR 211.46(b)Cited across public-safe Form 483 observations1x
21 CFR 600.14(c)Cited across public-safe Form 483 observations1x
21 CFR 820.100(b)Cited across public-safe Form 483 observations1x
21 CFR 820.30(f)Cited across public-safe Form 483 observations1x
21 CFR 820.30(g)Cited across public-safe Form 483 observations1x
21 CFR 820.50(a)(3)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind F. Hoffmann-La Roche AG's 8 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