FDA Inspection 1226666 — Daito Pharmaceutical Co., Ltd.
The FDA completed an inspection of Daito Pharmaceutical Co., Ltd. on Dec 19, 2023 in Toyama. 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)
- End Date
- Dec 19, 2023
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Toyama (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |