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Shire Human Genetic Therapies, Inc. — FDA Facility Profile

FEI 3009340644

Shire Human Genetic Therapies, Inc. is an FDA-registered facility (FEI 3009340644) located in Lexington, MA, US. Registered operations: ANALYSIS; MANUFACTURE. RegDataLab tracks 10 or more FDA inspections at this facility.

Facility Details

Location
Lexington, MA (US)
Registration Expires
December 31, 2026
Operations
ANALYSIS; MANUFACTURE
Source
both

Recent inspections

  • 1297340 (VAI Thu Dec 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1167818 (VAI Fri Apr 22 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1116968 (NAI Wed Jan 15 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1061705 (VAI Wed Jul 25 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1004081 (VAI Fri Jan 20 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 982412 (NAI Thu Jul 28 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 944256 (VAI Fri Aug 14 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 939368 (VAI Wed Jul 15 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 891161 (VAI Wed Aug 06 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 833938 (VAI Thu May 23 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Import refusals

  • AEK-5356975-9/21/1 (Tue Dec 04 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources