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Facility profile

ABBE Laboratories, Inc.

Drug product manufacturing · Farmingdale, NY

FDA recordFDA directory updated Jul 21, 2026Profile not yet claimed
Potential fit

Listed operations

The U.S. Food and Drug Administration (FDA) record lists broad activities for this site. Confirm specific services and availability directly.

ManufactureRepack
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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
Official action indicated (OAI)

Feb 27, 2025 · The findings may warrant official FDA action.

Matched compliance actions
Warning Letter · Aug 2025

Within five years · review the action and follow-up.

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Shows

Registration status and a latest matched official 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 history8 inspection records

FDA inspection history

8 records, Sep 2009 – Feb 2025 · 1 NAI · 6 VAI · 1 OAI

DateClassProject areaCitationsFY
Feb 27, 2025OAIDrug Quality AssuranceYes2025
Aug 9, 2018VAIDrug Quality Assurance2018
Jul 24, 2014VAIDrug Quality Assurance2014
Apr 12, 2013VAIDrug Quality AssuranceYes2013
May 23, 2012NAIDrug Quality Assurance2012
May 5, 2011VAIDrug Quality AssuranceYes2011
Mar 23, 2010VAIDrug Quality AssuranceYes2010
Sep 25, 2009VAIDrug Quality AssuranceYes2009

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

Matched compliance actions

Aug 6, 2025Warning Letter · CDER
Unclaimed profile

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