FDA Inspection 1288506 — CareFusion 213, LLC
The FDA completed an inspection of CareFusion 213, LLC on Oct 24, 2025 in El Paso, TX. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Oct 24, 2025
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- El Paso, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1270 | 21 CFR 211.68(b) | input/output verification |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |