FDA Inspection 809863 — Fresenius U.S.A. Manufacturing
The FDA completed an inspection of Fresenius U.S.A. Manufacturing on December 27, 2012 in Oregon, OH. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- December 27, 2012
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Oregon, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |