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Facility profile

Apothecus Pharmaceutical Corp.

Drug product manufacturing · HICKSVILLE, NY

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)

Nov 15, 2024 · FDA documented observations for voluntary correction.

Matched compliance actions
Past action on file · 2019

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 history8 inspection records

FDA inspection history

8 records, Jul 2009 – Nov 2024 · 5 NAI · 1 VAI · 2 OAI

DateClassProject areaCitationsFY
Nov 15, 2024VAIDrug Quality AssuranceYes2025
Oct 6, 2023OAIDrug Quality AssuranceYes2024
May 17, 2021OAIDrug Quality AssuranceYes2021
Jul 23, 2014NAIDrug Quality Assurance2014
Jun 27, 2012NAIDrug Quality Assurance2012
May 25, 2011NAIDrug Quality Assurance2011
Mar 10, 2010NAIDrug Quality Assurance2010
Jul 21, 2009NAIDrug Quality Assurance2009

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

Matched compliance actions

Nov 8, 2019Warning 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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