1259059
Turbare Manufacturing — FEI 3027507354
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 24, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Conway, AR (United States)
Citations
| ID | CFR | Description |
|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3616 | 21 CFR 211.165(d) | Acceptance criteria for sampling & testing |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |