1062902
ASP Cares — FEI 3012174424
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 23, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- San Antonio, TX (United States)
Citations
| ID | CFR | Description |
|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1433 | 21 CFR 211.42(c)(10)(iii) | Air Supply |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 2205 | 21 CFR 211.186(b)(9) | Manufacturing Instructions and Specifications |
| 4405 | 21 CFR 211.194(a)(2) | Statement of methods and data |