Labverity
Facility profile

Xttrium Laboratories, Inc.

Drug product manufacturing · Active pharmaceutical ingredient (API) manufacturing · Mount Prospect, IL

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.

Active pharmaceutical ingredient (API) manufactureLabelManufacturePack
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
Official action indicated (OAI)

Jun 18, 2025 · The findings may warrant official FDA action.

Matched compliance actions
Past action on file · 2009

More than five years old · review later records.

Understand this record

Use the evidence, then ask for fit.

Shows

Registration status and a latest matched official action indicated inspection.

Doesn’t show

Exact services, availability, capacity, pricing, or overall quality.

Ask next

Review the underlying findings, response, and subsequent follow-up before qualification.

Method and source details
View full inspection and compliance history16 inspection records

FDA inspection history

16 records, Dec 2008 – Jun 2025 · 6 NAI · 8 VAI · 2 OAI

DateClassProject areaCitationsFY
Jun 18, 2025OAIDrug Quality Assurance2025
Mar 8, 2024VAIDrug Quality Assurance2024
Feb 6, 2024NAIBioresearch Monitoring2024
Mar 15, 2018VAIDrug Quality AssuranceYes2018
Jul 11, 2016VAIDrug Quality AssuranceYes2016
May 25, 2016VAIBioresearch Monitoring2016
Dec 5, 2013VAIDrug Quality AssuranceYes2014
Jan 15, 2013NAIBioresearch Monitoring2013
Dec 11, 2012NAIDrug Quality Assurance2013
Oct 20, 2011NAIDrug Quality Assurance2012
Jul 18, 2011VAIDrug Quality Assurance2011
Jul 18, 2011VAIPostmarket Surv. and Epidemiology2011
Jul 16, 2010NAIDrug Quality Assurance2010
Feb 19, 2010VAIDrug Quality AssuranceYes2010
Aug 20, 2009NAIDrug Quality Assurance2009
Dec 31, 2008OAIDrug Quality AssuranceYes2009

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

Matched compliance actions

May 20, 2009Warning Letter · CDER
Unclaimed profile

Service details not yet provided

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

Ask about services