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FDA Inspection 1297340 — Shire Human Genetic Therapies, Inc.

Shire Human Genetic Therapies, Inc. — FEI 3009340644

The FDA completed an inspection of Shire Human Genetic Therapies, Inc. on December 18, 2025 in Lexington, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 18, 2025
Fiscal Year
2026
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Lexington, MA (United States)

Facility

Other inspections at this facility

  • 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))

FDA data resources