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Facility profile

Crown Laboratories

Drug product manufacturing · Johnson City, TN

FDA recordFDA directory updated Jul 21, 2026Profile not yet claimed
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Listed operations

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Manufacture
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 19, 2025 · 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 history9 inspection records

FDA inspection history

9 records, Nov 2011 – Sep 2025 · 2 NAI · 5 VAI · 2 OAI

DateClassProject areaCitationsFY
Sep 19, 2025VAIDrug Quality AssuranceYes2025
Mar 15, 2018NAIDrug Quality Assurance2018
Feb 15, 2018NAIBioresearch Monitoring2018
Apr 8, 2016VAIBioresearch MonitoringYes2016
Sep 24, 2014OAIUnapproved and Misbranded Drugs2014
Feb 14, 2014VAIDrug Quality AssuranceYes2014
Feb 14, 2014OAIUnapproved and Misbranded DrugsYes2014
Mar 9, 2012VAIDrug Quality AssuranceYes2012
Nov 3, 2011VAIDrug Quality AssuranceYes2012

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

Matched compliance actions

Jul 25, 2017Injunction · CDER
Unclaimed profile

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