FDA Inspection 988237 — Takeda Pharmaceuticals USA, Inc.
The FDA completed an inspection of Takeda Pharmaceuticals USA, Inc. on September 9, 2016 in Deerfield, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 9, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Deerfield, IL (United States)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 6728 | 21 CFR 314.80(b) | Failure to review ADE information |
| 6732 | 21 CFR 314.80(c)(1)(i) | Late submission of 15-day report |
| 6736 | 21 CFR 314.80(c)(1)(ii) | Submission of report follow-up |