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Facility profile

Bayer HealthCare LLC

Testing & analysis · Drug product manufacturing · Berkeley, CA

FDA recordFDA directory updated Jul 21, 2026Profile not yet claimed
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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) manufactureLabelManufacturePack
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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
No action indicated (NAI)

Oct 30, 2024 · No conditions warranted FDA action in this inspection.

Matched compliance actions
None in our records

No warning letter, injunction, or seizure matched.

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Shows

Registration status and a latest matched no 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 history12 inspection records

FDA inspection history

12 records, Feb 2009 – Oct 2024 · 2 NAI · 10 VAI · 0 OAI

DateClassProject areaCitationsFY
Oct 30, 2024NAIBlood and Blood Products2025
Aug 26, 2022VAIDrug Quality AssuranceYes2022
Nov 21, 2019VAIBlood and Blood Products2020
Sep 21, 2018VAIBlood and Blood Products2018
Dec 13, 2016VAIDrug Quality Assurance2017
Sep 19, 2013VAIBlood and Blood Products2013
May 24, 2013VAIDrug Quality AssuranceYes2013
Aug 12, 2011VAIBlood and Blood Products2011
Sep 10, 2010NAIDrug Quality Assurance2010
Jun 19, 2009VAIBlood and Blood Products2009
Jun 19, 2009VAIHuman Cellular, Tissue, and Gene Therapies2009
Feb 5, 2009VAIDrug Quality AssuranceYes2009

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

Matched compliance actions

No warning letter, injunction, or seizure is matched in the current data set.

Unclaimed profile

Service details not yet provided

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

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