Company
United StatesFresenius Kabi USA, LLC, Grand Island, NY – FDA Inspections
Inspection records and compliance data for Fresenius Kabi USA, LLC in Grand Island, New York. 16 FDA inspections on record (2 OAI), 7 Form 483s, last inspected May 14, 2026.
Company Profile
This profile covers Fresenius Kabi USA, LLC based in Grand Island, New York, United States.
FDA Inspection History
- FDA inspections
- 16
- OAI
- 2
- VAI
- 9
- NAI
- 3
- Unclassified
- 2
- Form 483s
- 7
- Warning letters
- 0
First inspected October 31, 2008. Last inspected May 14, 2026.
Most cited issue areas
- Investigations of discrepancies, failures4 inspections
- Procedures not in writing, fully followed4 inspections
- Procedures for sterile drug products3 inspections
FDA inspections (16)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 14, 2026 | Not classified | Human Drugs · Drug Quality Assurance | 1317954 |
| October 13, 2023 | VAI | Human Drugs · Drug Quality Assurance | 1220482 |
| August 30, 2023 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1216357 |
| August 12, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1099323 |
| June 29, 2018 | Not classified | Human Drugs | 1059868 |
| March 30, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1014707 |
| February 1, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1002820 |
| February 4, 2016 | VAI | Human Drugs · Drug Quality Assurance | 962308 |
| October 24, 2014 | VAI | Foods & Cosmetics, Human Drugs · Drug Quality Assurance | 901775 |
| January 11, 2013 | OAI | Human Drugs · Drug Quality Assurance | 815426 |
| August 29, 2011 | VAI | Human Drugs · Drug Quality Assurance | 741861 |
| July 8, 2011 | OAI | Human Drugs · Drug Quality Assurance | 732653 |
| January 13, 2010 | VAI | Human Drugs · Drug Quality Assurance | 640082 |
| September 17, 2009 | VAI | Human Drugs · Drug Quality Assurance | 613342 |
| March 5, 2009 | NAI | Human Drugs · Drug Quality Assurance | 579784 |
| October 31, 2008 | NAI | Human Drugs · Drug Quality Assurance | 545077 |
FDA documents
Form 483s (10)
People (6)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Fresenius Kabi USA, LLC
FEI Number
3001833549
Address
3159 Staley Rd, Grand Island, New York 14072, United States
Country
United States
ID: f0c47fa1-3b76-4e6c-82dd-d703086bdfdc