FDA Inspection 988705 — Fresenius Kabi USA, LLC
The FDA completed an inspection of Fresenius Kabi USA, LLC on June 24, 2016 in Wilson, NC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 24, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Wilson, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1630 | 21 CFR 211.130(b) | Unlabeled filled containers controls |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 2024 | 21 CFR 211.188(b)(12) | Documentation of Batch Investigations |