Company
United StatesFresenius USA Manufacturing, Inc, Knoxville, TN – FDA Inspections
Inspection records and compliance data for Fresenius USA Manufacturing, Inc in Knoxville, Tennessee. 6 FDA inspections on record, 1 Form 483, last inspected September 19, 2025.
Company Profile
This profile covers Fresenius USA Manufacturing, Inc based in Knoxville, Tennessee, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 2
- NAI
- 3
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected October 6, 2017. Last inspected September 19, 2025.
Most cited issue areas
- Deviations from laboratory control requirements1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 19, 2025 | Not classified | Human Drugs | 1284734 |
| October 18, 2024 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1251719 |
| December 7, 2022 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1195086 |
| June 26, 2020 | VAI | Human Drugs · Drug Quality Assurance | 1124187 |
| September 12, 2019 | NAI | Human Drugs · Drug Quality Assurance | 1110322 |
| October 6, 2017 | VAI | Human Drugs · New Drug Evaluation | 1028853 |
FDA documents
Form 483s (1)
People (1)
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Company Information
Name
Fresenius USA Manufacturing, Inc
FEI Number
3013546115
Address
5105 S National Dr, Knoxville, Tennessee 37914, United States
Country
United States
ID: 6a1a5f30-4674-4964-a33e-c6401405fba9