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Facility profile

Shire Human Genetic Therapies, Inc.

Testing & analysis · Active pharmaceutical ingredient (API) manufacturing · Lexington, MA

FDA recordFDA directory updated Jul 22, 2026Profile not yet claimed6 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.

AnalysisActive 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 22, 2026

Latest matched inspection
Voluntary action indicated (VAI)

Dec 18, 2025 · 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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Ask what was corrected and review any later inspection or follow-up record.

Method and source details
View full inspection and compliance history23 inspection records

FDA inspection history

23 records, Dec 2008 – Dec 2025 · 7 NAI · 16 VAI · 0 OAI

DateClassProject areaCitationsFY
Dec 18, 2025VAIDrug Quality Assurance2026
Apr 22, 2022VAIDrug Quality Assurance2022
Jan 15, 2020NAIDrug Quality Assurance2020
Jul 25, 2018VAIBioresearch Monitoring2018
Jul 25, 2018VAIBioresearch Monitoring2018
Jan 20, 2017VAIDrug Quality Assurance2017
Jul 28, 2016NAIBioresearch Monitoring2016
Jul 28, 2016NAIBioresearch Monitoring2016
Aug 14, 2015VAIDrug Quality Assurance2015
Jul 15, 2015VAIDrug Quality AssuranceYes2015
Aug 6, 2014VAIBioresearch MonitoringYes2014
May 23, 2013VAIDrug Quality Assurance2013
Aug 31, 2012VAIDrug Quality Assurance2012
Apr 2, 2012NAIBioresearch Monitoring2012
Feb 1, 2012VAIDrug Quality Assurance2012
Jan 11, 2012VAIDrug Quality Assurance2012
Jul 8, 2011VAIDrug Quality Assurance2011
Jul 8, 2011VAIPostmarket Surv. and Epidemiology2011
Aug 26, 2010NAIBioresearch Monitoring2010
Jan 7, 2010VAIBioresearch MonitoringYes2010
Nov 20, 2009VAIDrug Quality Assurance2010
Mar 5, 2009NAIDrug Quality Assurance2009
Dec 17, 2008NAIBioresearch Monitoring2009

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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