1007167
RC Outsourcing, LLC — FEI 3011967886
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 31, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Lowellville, OH (United States)
Citations
| ID | CFR | Description |
|---|
| 1159 | 21 CFR 211.28(a) | Clothing appropriate for duties performed |
| 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 |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1932 | 21 CFR 211.167(a) | Sterility/pyrogen-free testing |
| 1933 | 21 CFR 211.167(a) | Sterility/pyrogens - test methods written, followed |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |