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Facility profile

Bayer AG

Testing & analysis · Drug product manufacturing · Leverkusen · Germany

FDA recordFDA directory updated Jul 21, 2026Profile not yet claimed5 registered company locations
Potential fit

Listed operations

The U.S. Food and Drug Administration (FDA) record lists broad activities for this site. Confirm specific services and availability directly.

AnalysisActive pharmaceutical ingredient (API) manufactureLabelManufacturePackParticle Size Reduction
Due diligence

Regulatory record at a glance

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Registration record
Current FDA registration record

Expires Dec 31, 2026 · checked Jul 21, 2026

Latest matched inspection
Voluntary action indicated (VAI)

Sep 7, 2023 · FDA documented observations for voluntary correction.

Matched compliance actions
Past action on file · 2017

More than five years old · review later records.

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Shows

Registration status and a latest matched voluntary action indicated inspection.

Doesn’t show

Exact services, availability, capacity, pricing, or overall quality.

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Method and source details
View full inspection and compliance history9 inspection records

FDA inspection history

9 records, Feb 2010 – Sep 2023 · 2 NAI · 5 VAI · 2 OAI

DateClassProject areaCitationsFY
Sep 7, 2023VAIDrug Quality Assurance2023
May 13, 2022NAIDrug Quality Assurance2022
Jul 27, 2020VAIDrug Quality AssuranceYes2020
Mar 22, 2019OAIDrug Quality AssuranceYes2019
Jan 20, 2017OAIDrug Quality Assurance2017
Jun 3, 2016NAIDrug Quality Assurance2016
Nov 14, 2014VAIDrug Quality Assurance2015
Jul 9, 2012VAIDrug Quality Assurance2012
Feb 23, 2010VAIDrug Quality Assurance2010

No action indicated (NAI) · Voluntary action indicated (VAI) · Official action indicated (OAI)

Matched compliance actions

Nov 14, 2017Warning Letter · CDER
Unclaimed profile

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Methods, equipment, quality scope, capacity, turnaround, and commercial contacts are not available.

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