Company
United StatesFresenius U.S.A. Manufacturing, Oregon, OH – FDA Inspections
Inspection records and compliance data for Fresenius U.S.A. Manufacturing in Oregon, Ohio. 4 FDA inspections on record, 1 Form 483, last inspected May 08, 2023.
Company Profile
This profile covers Fresenius U.S.A. Manufacturing based in Oregon, Ohio, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected June 15, 2010. Last inspected May 8, 2023.
Most cited issue areas
- Lack of or inadequate procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 8, 2023 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1206544 |
| June 30, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1016670 |
| December 27, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 809863 |
| June 15, 2010 | NAI | Medical Devices & Rad Health · Compliance: Devices | 667215 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Fresenius U.S.A. Manufacturing
FEI Number
1527681
Address
750 N Lallendorf Rd, Oregon, Ohio 43616, United States
Country
United States
ID: d7fc621f-9400-4de0-bc05-4542deabe147