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FDA Inspection 1281538 — Shire Human Genetic Therapies Inc

Shire Human Genetic Therapies Inc — FEI 3005955297

The FDA completed an inspection of Shire Human Genetic Therapies Inc on September 12, 2025 in Cambridge, 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
September 12, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Cambridge, MA (United States)

Facility

Other inspections at this facility

  • 1041102 (VAI Thu Feb 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 945326 (NAI Fri Sep 04 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 844642 (VAI Mon Aug 05 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 727622 (NAI Thu Jun 02 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 725761 (VAI Thu May 19 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

FDA data resources