FDA Inspection 807882 — Shionogi Inc.
The FDA completed an inspection of Shionogi Inc. on November 5, 2012 in Florham Park, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 5, 2012
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Florham Park, NJ (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 7459 | 21 CFR 312.57(a) | Records of receipt, shipment, disposition |
| 7507 | 21 CFR 312.52(a) | Transfer of obligations |