FDA Inspection 1297340 — Shire Human Genetic Therapies, Inc.
The FDA completed an inspection of Shire Human Genetic Therapies, Inc. on Dec 18, 2025 in Lexington, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 18, 2025
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Lexington, MA (United States)