1167934
US Specialty Formulations LLC — FEI 3010680515
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 26, 2022
- Fiscal Year
- 2022
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Allentown, PA (United States)
Citations
| ID | CFR | Description |
|---|
| 1162 | 21 CFR 211.28(a) | Protective Apparel Not Worn |
| 1169 | 21 CFR 211.42(a) | Buildings of Suitable Size, Construction, Location |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 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 |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 18008 | FDCA 503B(a)(10) | Drug product label, outsourcer facility |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1868 | 21 CFR 211.94(b) | Protection from external factors |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3604 | 21 CFR 211.160(b)(1) | Determination of conformance |