FDA Inspection 891161 — Shire Human Genetic Therapies, Inc.
The FDA completed an inspection of Shire Human Genetic Therapies, Inc. on Aug 6, 2014 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). 1 citation was issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 6, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Lexington, MA (United States)
Additional details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 6732 | 21 CFR 314.80(c)(1)(i) | Late submission of 15-day report |