FDA Inspection 1201161 — TERUMO YAMAGUCHI CORPORATION
The FDA completed an inspection of TERUMO YAMAGUCHI CORPORATION on March 30, 2023 in Yamaguchi. 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
- March 30, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Yamaguchi (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 1802 | 21 CFR 211.84(b) | Representative Samples |
| 4305 | 21 CFR 211.68(b) | Backup data not assured as exact and complete |