FDA Inspection 1111495 — Takeda Pharmaceutical Company Limited
The FDA completed an inspection of Takeda Pharmaceutical Company Limited on November 26, 2019 in Hikari. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 26, 2019
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hikari (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |