Atlas

FDA-Inspected Site

Bayer Weimar GmbH und Co. KG

6 FDA inspections are on record for Bayer Weimar GmbH und Co. KG in Weimar, Germany.

483· Form 483 issued

Weimar, Germany · Last updated July 10, 2026

Overview

  • 6 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2019-09-13.

At a glance

Inspections

6

Form 483s

2

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
9 Sep 2019 – 13 Sep 2019Human Drugs483View 483 →
2 Nov 2015 – 5 Nov 2015Human DrugsClean
19 Oct 2012Not recordedClean
4 Dec 2009Not recorded483On file
14 Oct 2004Not recordedClean
22 Mar 2001Not recordedClean

Observations on record

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

13 Sep 2019
21 CFR 211.192

Extent of discrepancy, failure investigations

Cited by John P Mistler

13 Sep 2019
21 CFR 211.84(c)(4)

Top/Middle/Bottom container sampling

Cited by John P Mistler

13 Sep 2019
21 CFR 211.84(d)(2)

Establish reliability of supplier's C of A

Cited by John P Mistler

Investigators

FDA investigators tied to this site in the record.

John P Mistler1 insp.
Timothy T Kapsala1 insp.
Karen L Kosar1 insp.
Matthew B Casale1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.84(c)(4)Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(2)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Bayer Weimar GmbH und Co. KG's 2 Form 483s

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