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Facility profile

Bayer AG

Testing & analysis · Active pharmaceutical ingredient (API) manufacturing · Bergkamen · 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) manufacture
Due diligence

Regulatory record at a glance

Use these records to guide qualification; they are not a facility score.

Registration record
Current FDA registration record

Expires Dec 31, 2026 · checked Jul 21, 2026

Latest matched inspection
Voluntary action indicated (VAI)

Nov 14, 2024 · FDA documented observations for voluntary correction.

Matched compliance actions
Past action on file · 2009

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 history7 inspection records

FDA inspection history

7 records, Mar 2009 – Nov 2024 · 3 NAI · 3 VAI · 1 OAI

DateClassProject areaCitationsFY
Nov 14, 2024VAIDrug Quality Assurance2025
Oct 10, 2019VAIDrug Quality Assurance2020
Jun 15, 2018NAIDrug Quality Assurance2018
Nov 12, 2015NAIDrug Quality Assurance2016
May 24, 2013VAIDrug Quality Assurance2013
Feb 12, 2010NAIDrug Quality Assurance2010
Mar 10, 2009OAIDrug Quality Assurance2009

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

Matched compliance actions

Aug 5, 2009Warning Letter · CDER
Unclaimed profile

Service details not yet provided

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

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