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US Specialty Formulations LLC

Active pharmaceutical ingredient (API) manufacturing · Allentown, PA

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.

Active pharmaceutical ingredient (API) manufacture
Due diligence

Regulatory record at a glance

Use these records to guide qualification; they are not a facility score.

Registration record
Current FDA registration record

Expires Dec 31, 2026 · checked Jul 21, 2026

Latest matched inspection
Voluntary action indicated (VAI)

Mar 26, 2025 · FDA documented observations for voluntary correction.

Matched compliance actions
Warning Letter · Jul 2023

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

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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, Mar 2014 – Mar 2025 · 1 NAI · 1 VAI · 6 OAI

DateClassProject areaCitationsFY
Mar 26, 2025VAIDrug Quality AssuranceYes2025
Jul 2, 2024OAIDrug Quality Assurance2024
Apr 26, 2022OAIDrug Quality AssuranceYes2022
Apr 26, 2022OAIMonitoring of Marketed Animal Drugs, Feed, and DevicesYes2022
Jul 23, 2019OAIDrug Quality AssuranceYes2019
Aug 29, 2017OAIDrug Quality AssuranceYes2017
May 29, 2015OAIDrug Quality AssuranceYes2015
Mar 18, 2014NAIDrug Quality Assurance2014

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

Matched compliance actions

Jul 26, 2023Warning Letter · CDER
Sep 30, 2016Warning Letter · CDER
Unclaimed profile

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