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Bayer Weimar GmbH Und Co. KG FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Bayer Weimar GmbH Und Co. KG has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Bayer Weimar GmbH Und Co. KG" is on file.

What these totals cover: FDA records filed under the name "Bayer Weimar GmbH Und Co. KG".

Latest inspection: Nov 24, 2022 · VAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	5	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Bayer Weimar GmbH Und Co. KG's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	0	0	0	0	0
2024	0	0	0	0	0
2023	0	0	0	0	0
2022	1	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	1	0	0	0	0
2018	0	0	0	0	0
2017	0	0	0	0	0

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

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Recent FDA inspections

5 inspections from Dec 4, 2009 to Nov 24, 2022.

Date	Site	Product	Classification	FEI
Nov 24, 2022	Weimar, Germany	Drugs	Voluntary Action Indicated (VAI)	3002808091
Sep 13, 2019	Weimar, Germany	Drugs	Voluntary Action Indicated (VAI)	3002808091
Nov 5, 2015	Weimar, Germany	Drugs	No Action Indicated (NAI)	3002808091
Oct 19, 2012	Weimar, Germany	Drugs	No Action Indicated (NAI)	3002808091
Dec 4, 2009	Weimar, Germany	Drugs	Voluntary Action Indicated (VAI)	3002808091

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3002808091	Weimar, Germany	5	Nov 24, 2022

Bayer Weimar GmbH Und Co. KG and the FDA: common questions

Has Bayer Weimar GmbH Und Co. KG received an FDA warning letter?

No FDA warning letter addressed to the name "Bayer Weimar GmbH Und Co. KG" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Bayer Weimar GmbH Und Co. KG received an FDA Form 483?

FDA has not published a Form 483 for "Bayer Weimar GmbH Und Co. KG" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Bayer Weimar GmbH Und Co. KG?

The most recent FDA inspection on file ended Nov 24, 2022 at Weimar, Germany and was classified VAI. FDA has 5 inspections of Bayer Weimar GmbH Und Co. KG on file.

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