FDA Inspection 1015133 — Nephron SC, LLC
The FDA completed an inspection of Nephron SC, LLC on April 21, 2017 in West Columbia, SC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
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 |