FDA Inspection 1229051 — Nephron SC, LLC
The FDA completed an inspection of Nephron SC, LLC on Feb 9, 2024 in West Columbia, SC. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Feb 9, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- West Columbia, SC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |