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Facility profile

Simtra US LLC

Testing & analysis · Drug product manufacturing · Bloomington, IN

FDA recordFDA directory updated Jul 21, 2026Profile not yet claimed2 registered company locations
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.

AnalysisLabelManufacturePackRelabelSterilize
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)

Sep 24, 2024 · FDA documented observations for voluntary correction.

Matched compliance actions
None in our records

No warning letter, injunction, or seizure matched.

Understand this record

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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 history21 inspection records

FDA inspection history

21 records, Oct 2009 – Sep 2024 · 6 NAI · 15 VAI · 0 OAI

DateClassProject areaCitationsFY
Sep 24, 2024VAIDrug Quality Assurance2024
Feb 17, 2023NAIDrug Quality Assurance2023
Nov 10, 2021VAIVaccines and Allergenic Products2022
May 23, 2018VAIBlood and Blood Products2018
May 23, 2018VAIVaccines and Allergenic Products2018
Jul 17, 2017VAIDrug Quality AssuranceYes2017
May 12, 2016VAIBlood and Blood Products2016
May 12, 2016VAIVaccines and Allergenic Products2016
Oct 24, 2014VAIDrug Quality Assurance2015
May 2, 2014NAIDrug Quality Assurance2014
May 10, 2013VAIDrug Quality AssuranceYes2013
Mar 12, 2013VAIDrug Quality AssuranceYes2013
Sep 27, 2012VAIDrug Quality Assurance2012
Aug 16, 2011NAIDrug Quality Assurance2011
Jun 17, 2011NAIVaccines and Allergenic Products2011
Mar 25, 2011VAIDrug Quality AssuranceYes2011
Sep 23, 2010VAIDrug Quality Assurance2010
Mar 24, 2010VAIBlood and Blood Products2010
Mar 24, 2010VAIVaccines and Allergenic Products2010
Oct 30, 2009NAIMonitoring of Marketed Animal Drugs, Feed, and Devices2010
Oct 30, 2009NAIDrug Quality Assurance2010

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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