Company
United StatesFresenius Kabi USA, LLC, North Andover, MA – FDA Inspections
Inspection records and compliance data for Fresenius Kabi USA, LLC in North Andover, Massachusetts. 3 FDA inspections on record (2 OAI), 2 Form 483s, last inspected August 08, 2025.
Company Profile
This profile covers Fresenius Kabi USA, LLC based in North Andover, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 2
- VAI
- 0
- NAI
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected March 18, 2022. Last inspected August 8, 2025.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures2 inspections
- Lack of or inadequate procedures2 inspections
- Design input - Lack of or inadequate procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 8, 2025 | OAI | Medical Devices & Rad Health · Compliance: Devices | 1278050 |
| September 7, 2023 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1217750 |
| March 18, 2022 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1164862 |
FDA documents
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Fresenius Kabi USA, LLC
FEI Number
3014732157
Address
50 High St Ste 50, North Andover, Massachusetts 01845, United States
Country
United States
ID: f0976e16-40e3-475b-8dc0-c9e721658b4a