1167490
Nephron SC, LLC — FEI 3010892830
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 20, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- West Columbia, SC (United States)
Citations
| ID | CFR | Description |
|---|
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1876 | 21 CFR 211.180(b) | Record maintenance 1 year (except exempt OTC) |
| 1933 | 21 CFR 211.167(a) | Sterility/pyrogens - test methods written, followed |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2406 | 21 CFR 211.194(a)(8) | Identification of Person Performing Review of Lab Records |