1191695
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 11, 2022
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Bayan Lepas (Malaysia)
Additional Details
Postmarket Audit Inspections
Citations
| ID | CFR | Description |
|---|---|---|
| 3159 | 21 CFR 820.184 | DHR content |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |