1217356
Aso Pharmaceutical Company, Ltd — FEI 1000414460
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 8, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Kikuchi-Gun (Japan)
Citations
| ID | CFR | Description |
|---|
| 1169 | 21 CFR 211.42(a) | Buildings of Suitable Size, Construction, Location |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1922 | 21 CFR 211.166(a)(4) | Testing in same container - closure system |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |