1093987
Hybrid Pharma LLC — FEI 3011319445
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 20, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Deerfield Beach, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1430 | 21 CFR 211.42(c)(10)(i) | Floors, walls, ceiling surfaces |
| 1433 | 21 CFR 211.42(c)(10)(iii) | Air Supply |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 18008 | FDCA 503B(a)(10) | Drug product label, outsourcer facility |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |