FDA Inspection 1208748 — TOYO Pharmaceutical Co., Ltd.
The FDA completed an inspection of TOYO Pharmaceutical Co., Ltd. on June 16, 2023 in Osaka. 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
- June 16, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Osaka (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |