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Chemolee Lab Corporation

Drug product manufacturing · Packaging & labeling · Irving, TX

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.

ManufacturePack
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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)

May 30, 2025 · FDA documented observations for voluntary correction.

Matched compliance actions
Past action on file · 2016

More than five years old · review later records.

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Shows

Registration status and a latest matched voluntary action indicated inspection.

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Method and source details
View full inspection and compliance history8 inspection records

FDA inspection history

8 records, Dec 2009 – May 2025 · 1 NAI · 5 VAI · 2 OAI

DateClassProject areaCitationsFY
May 30, 2025VAIDrug Quality AssuranceYes2025
Feb 10, 2020NAIDrug Quality Assurance2020
May 18, 2017VAIDrug Quality AssuranceYes2017
Feb 13, 2015OAIDrug Quality AssuranceYes2015
Jul 18, 2013VAIColors and Cosmetics TechnologyYes2013
Jul 18, 2013VAIDrug Quality AssuranceYes2013
Sep 1, 2011OAIDrug Quality AssuranceYes2011
Dec 21, 2009VAIDrug Quality AssuranceYes2010

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

Matched compliance actions

Feb 23, 2016Warning Letter · CDER
Unclaimed profile

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