FDA Inspection 783661 — Fresenius Kabi USA, LLC
The FDA completed an inspection of Fresenius Kabi USA, LLC on May 4, 2012 in Lake Zurich, IL. 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
- May 4, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Lake Zurich, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 6706 | 21 CFR 310.305(c)(1)(i) | Late submission |
| 6732 | 21 CFR 314.80(c)(1)(i) | Late submission of 15-day report |
| 6832 | 21 CFR 314.80(c)(2) | Late submission of annual safety reports |