Company
United StatesShire Human Genetic Therapies, Inc., Lexington, MA – FDA Inspections
Inspection records and compliance data for Shire Human Genetic Therapies, Inc. in Lexington, Massachusetts. 21 FDA inspections on record, 3 Form 483s, last inspected December 18, 2025.
Company Profile
This profile covers Shire Human Genetic Therapies, Inc. based in Lexington, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 21
- OAI
- 0
- VAI
- 13
- NAI
- 6
- Unclassified
- 2
- Form 483s
- 3
- Warning letters
- 0
First inspected December 17, 2008. Last inspected December 18, 2025.
Most cited issue areas
- General responsibilities of sponsors1 inspection
- Investigator non-compliance1 inspection
- Late submission of 15-day report1 inspection
FDA inspections (21)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 18, 2025 | Not classified | Human Drugs | 1297340 |
| April 22, 2022 | VAI | Human Drugs · Drug Quality Assurance | 1167818 |
| January 15, 2020 | NAI | Human Drugs · Drug Quality Assurance | 1116968 |
| November 9, 2018 | Not classified | Medical Devices & Rad Health | 1106210 |
| July 25, 2018 | VAI | Human Drugs · Bioresearch Monitoring | 1061705 |
| January 20, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1004081 |
| July 28, 2016 | NAI | Human Drugs · Bioresearch Monitoring | 982412 |
| August 14, 2015 | VAI | Human Drugs · Drug Quality Assurance | 944256 |
| July 15, 2015 | VAI | Human Drugs · Drug Quality Assurance | 939368 |
| August 6, 2014 | VAI | Human Drugs · Bioresearch Monitoring | 891161 |
| May 23, 2013 | VAI | Human Drugs · Drug Quality Assurance | 833938 |
| August 31, 2012 | VAI | Human Drugs · Drug Quality Assurance | 812437 |
| April 2, 2012 | NAI | Human Drugs · Bioresearch Monitoring | 776067 |
| February 1, 2012 | VAI | Human Drugs · Drug Quality Assurance | 765452 |
| January 11, 2012 | VAI | Human Drugs · Drug Quality Assurance | 762797 |
| July 8, 2011 | VAI | Human Drugs · Postmarket Surv. and Epidemiology | 734060 |
| August 26, 2010 | NAI | Human Drugs · Bioresearch Monitoring | 679511 |
| January 7, 2010 | VAI | Human Drugs · Bioresearch Monitoring | 639283 |
| November 20, 2009 | VAI | Human Drugs · Drug Quality Assurance | 633243 |
| March 5, 2009 | NAI | Human Drugs · Drug Quality Assurance | 570583 |
| December 17, 2008 | NAI | Human Drugs · Bioresearch Monitoring | 556819 |
FDA documents
People (6)
Related Companies (10)
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Company Information
Name
Shire Human Genetic Therapies, Inc.
FEI Number
3009340644
Address
300 Shire Way, Lexington, Massachusetts 02421, United States
Country
United States
ID: 7051823d-8cc7-4d72-8a82-a0de9bbb9497