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Facility profile

Sigmapharm Laboratories, LLC

Testing & analysis · Drug product manufacturing · Bensalem, PA

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.

AnalysisActive pharmaceutical ingredient (API) manufactureManufacture
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)

Dec 17, 2025 · FDA documented observations for voluntary correction.

Matched compliance actions
None in our records

No warning letter, injunction, or seizure matched.

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Shows

Registration status and a latest matched voluntary 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 history12 inspection records

FDA inspection history

12 records, Sep 2009 – Dec 2025 · 5 NAI · 7 VAI · 0 OAI

DateClassProject areaCitationsFY
Dec 17, 2025VAIDrug Quality AssuranceYes2026
Feb 13, 2023NAIDrug Quality Assurance2023
Dec 7, 2021NAIDrug Quality Assurance2022
Jun 13, 2018NAIBioresearch Monitoring2018
Jun 19, 2017VAIDrug Quality AssuranceYes2017
Jun 23, 2015NAIBioresearch Monitoring2015
Nov 19, 2014VAIDrug Quality AssuranceYes2015
Mar 20, 2014VAIDrug Quality Assurance2014
Aug 13, 2013VAIBioresearch MonitoringYes2013
Dec 22, 2011VAIDrug Quality Assurance2012
May 25, 2011VAIDrug Quality Assurance2011
Sep 25, 2009NAIDrug Quality Assurance2009

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

Matched compliance actions

No warning letter, injunction, or seizure is matched in the current data set.

Unclaimed profile

Service details not yet provided

Methods, equipment, quality scope, capacity, turnaround, and commercial contacts are not available.

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