FDA Inspection 1305990 — Fresenius USA Manufacturing, Inc.
The FDA completed an inspection of Fresenius USA Manufacturing, Inc. on Mar 6, 2026 in Ogden, UT. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Mar 6, 2026
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Ogden, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |