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Facility profile

Chemrite Copac LLC

Drug product manufacturing · Lannon, WI

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.

Manufacture
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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
Voluntary action indicated (VAI)

Apr 11, 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

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Method and source details
View full inspection and compliance history11 inspection records

FDA inspection history

11 records, Mar 2009 – Apr 2023 · 3 NAI · 6 VAI · 2 OAI

DateClassProject areaCitationsFY
Apr 11, 2023VAIDrug Quality Assurance2023
Jul 15, 2016OAIDrug Quality AssuranceYes2016
Jul 15, 2016OAIColors and Cosmetics TechnologyYes2016
Mar 24, 2016VAIColors and Cosmetics TechnologyYes2016
Mar 24, 2016VAIDrug Quality AssuranceYes2016
Feb 21, 2013VAICompliance: DevicesYes2013
Feb 21, 2013VAIDrug Quality AssuranceYes2013
Feb 21, 2013NAIColors and Cosmetics TechnologyYes2013
Nov 21, 2011VAIDrug Quality AssuranceYes2012
Mar 19, 2009NAIDrug Quality Assurance2009
Mar 19, 2009NAIColors and Cosmetics Technology2009

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

Matched compliance actions

Jun 29, 2017Warning Letter · CDER
Unclaimed profile

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