FDA Inspection 769358 — Astellas Pharma US Inc.
The FDA completed an inspection of Astellas Pharma US Inc. on Feb 27, 2012 in Northbrook, IL. 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). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 27, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Northbrook, IL (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 2940 | 21 CFR 812.43(c)(4)(i) | No investigation agreement statement of commitment |
| 7480 | 21 CFR 312.50 | Ensuring compliance with plan and protocol |