FDA Inspection 1155136 — Mitsubishi Tanabe Pharma America, Inc.
The FDA completed an inspection of Mitsubishi Tanabe Pharma America, Inc. on October 15, 2021 in Jersey City, 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
- October 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 |