FDA Inspection 857641 — Mitsubishi Tanabe Pharma America, Inc.
The FDA completed an inspection of Mitsubishi Tanabe Pharma America, Inc. on Dec 4, 2013 in Jersey City, NJ. 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
- Dec 4, 2013
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Jersey City, NJ (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 7482 | 21 CFR 312.50 | General responsibilities of sponsors |