Company
United StatesShire Human Genetic Therapies Inc, Cambridge, MA – FDA Inspections
Inspection records and compliance data for Shire Human Genetic Therapies Inc in Cambridge, Massachusetts. 8 FDA inspections on record, 2 Form 483s, last inspected September 12, 2025.
Company Profile
This profile covers Shire Human Genetic Therapies Inc based in Cambridge, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 0
- VAI
- 4
- NAI
- 3
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected November 20, 2009. Last inspected September 12, 2025.
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 12, 2025 | Not classified | Human Drugs | 1281538 |
| February 1, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1041102 |
| September 4, 2015 | NAI | Human Drugs · Drug Quality Assurance | 945326 |
| August 5, 2013 | VAI | Human Drugs · Drug Quality Assurance | 844642 |
| June 2, 2011 | NAI | Human Drugs · Drug Quality Assurance | 727622 |
| May 19, 2011 | VAI | Human Drugs · Drug Quality Assurance | 725761 |
| November 20, 2009 | NAI | Human Drugs · Drug Quality Assurance | 634001 |
| November 20, 2009 | VAI | Human Drugs · Drug Quality Assurance | 633283 |
FDA documents
Form 483s (1)
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Company Information
Name
Shire Human Genetic Therapies Inc
FEI Number
3005955297
Address
205 Alewife Brook Pkwy, Cambridge, Massachusetts 02138, United States
Country
United States
ID: 18935846-62b3-4ebf-b808-ad1f10eb713e