FDA Inspection 729730 — CareFusion 213, LLC
The FDA completed an inspection of CareFusion 213, LLC on Jun 3, 2011 in El Paso, TX. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jun 3, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- El Paso, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1852 | 21 CFR 211.94(a) | Reactive/Additive/Absorptive Containers/Closures |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |
| 4375 | 21 CFR 211.188(b)(5) | In-process and laboratory control results |
| 8911 | 21 CFR 314.81(b)(1)(ii) | Failure to meet specifications |