FDA Inspection 1155136 — Mitsubishi Tanabe Pharma America, Inc.
The FDA completed an inspection of Mitsubishi Tanabe Pharma America, Inc. on Oct 15, 2021 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). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 15, 2021
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Jersey City, NJ (United States)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 6730 | 21 CFR 314.80(b) | Failure to develop written procedures |
| 6831 | 21 CFR 314.80(c)(2) | Late submission of quarterly safety reports |