FDA Inspection 901775 — Fresenius Kabi USA, LLC
The FDA completed an inspection of Fresenius Kabi USA, LLC on October 24, 2014 in Grand Island, NY. 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
- October 24, 2014
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Grand Island, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1169 | 21 CFR 211.42(a) | Buildings of Suitable Size, Construction, Location |
| 1803 | 21 CFR 211.84(b) | Representative Samples Criteria |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |