FDA Inspection 1207312 — Morishita Jintan Co., Ltd.
The FDA completed an inspection of Morishita Jintan Co., Ltd. on May 19, 2023 in Inukami-Gun. 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
- May 19, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Inukami-Gun (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1929 | 21 CFR 211.166(c)(2) | Homeopathic drugs, same container - closure |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |