FDA Inspection 1061705 — Shire Human Genetic Therapies, Inc.
The FDA completed an inspection of Shire Human Genetic Therapies, Inc. on July 25, 2018 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
- July 25, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Lexington, MA (United States)
Additional Details
Risk Evaluation and Mitigation Strategies (REMS)