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Facility profile

LGM Pharma Solutions, LLC

Testing & analysis · Drug product manufacturing · Irvine, CA

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.

AnalysisLabelManufacturePack
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
No action indicated (NAI)

Jan 24, 2025 · No conditions warranted FDA action in this inspection.

Matched compliance actions
Warning Letter · Nov 2022

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

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Shows

Registration status and a latest matched no 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 history14 inspection records

FDA inspection history

14 records, Jan 2009 – Jan 2025 · 5 NAI · 6 VAI · 3 OAI

DateClassProject areaCitationsFY
Jan 24, 2025NAIBioresearch Monitoring2025
Mar 1, 2024VAIDrug Quality AssuranceYes2024
Jan 31, 2020NAIDrug Quality Assurance2020
Aug 17, 2018VAIBioresearch MonitoringYes2018
Feb 13, 2017NAIFood Composition, Standards, Labeling and Econ2017
Dec 13, 2016VAIDrug Quality Assurance2017
Jul 11, 2014VAIDrug Quality AssuranceYes2014
Apr 9, 2012VAIFood Composition, Standards, Labeling and EconYes2012
May 5, 2011NAIDrug Quality Assurance2011
Apr 22, 2010NAIDrug Quality Assurance2010
Apr 2, 2010OAIFood Composition, Standards, Labeling and Econ2010
Apr 2, 2010OAIUnapproved and Misbranded Drugs2010
Apr 2, 2010OAIDrug Quality Assurance2010
Jan 28, 2009VAIDrug Quality Assurance2009

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

Matched compliance actions

Nov 14, 2022Warning Letter · CFSAN
Sep 27, 2010Warning 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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