FDA Inspection 1142311 — Fresenius USA Manufacturing, Inc.
The FDA completed an inspection of Fresenius USA Manufacturing, Inc. on May 21, 2021 in Ogden, UT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 21, 2021
- Fiscal Year
- 2021
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Ogden, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |