1015133
Nephron SC, LLC — FEI 3010892830
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 21, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- West Columbia, SC (United States)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 18009 | FDCA 503B(a)(10) | Container label, outsourcer facility |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |