1027816
Baxter Laboratories Pty. Ltd. — FEI 3003945201
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 22, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Boronia (Australia)
Citations
| ID | CFR | Description |
|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2205 | 21 CFR 211.186(b)(9) | Manufacturing Instructions and Specifications |
| 3561 | 21 CFR 211.56(b) | Written sanitation procedures lacking |