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Fresenius Kabi USA, LLC, Melrose Park, IL – FDA Inspections

Inspection records and compliance data for Fresenius Kabi USA, LLC in Melrose Park, IL. 8 FDA inspections on record, last inspected August 28, 2025.

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Company Profile

This profile covers Fresenius Kabi USA, LLC based in Melrose Park, IL, United States.

FDA Inspection History

FDA inspections
8
OAI
0
VAI
1
NAI
7
Form 483s
0
Warning letters
0

First inspected March 3, 2009. Last inspected August 28, 2025.

FDA inspections (8)

DateResultFDA center(s)Insp. #
August 28, 2025NAIHuman Drugs · Drug Quality Assurance1291112
March 8, 2019NAIHuman Drugs · Drug Quality Assurance1085354
April 14, 2015NAIHuman Drugs · Drug Quality Assurance922406
December 17, 2013NAIHuman Drugs · Drug Quality Assurance859170
November 20, 2012VAIAnimal Drugs & Feeds, Human Drugs · Monitoring of Marketed Animal Drugs, Feed, and Devices807610
December 20, 2011NAIHuman Drugs · Drug Quality Assurance760383
January 29, 2010NAIAnimal Drugs & Feeds, Human Drugs, Medical Devices & Rad Health · Drug Quality Assurance640768
March 3, 2009NAIHuman Drugs · Drug Quality Assurance558967
FDA documents

EIRs (4)

  • EIRs · March 8, 2019
  • EIRs · April 14, 2015
  • EIRs · December 17, 2013
  • EIRs · November 20, 2012

Other FDA documents (4)

  • Other FDA documents
  • Other FDA documents
  • Other FDA documents
  • Other FDA documents
Other regulators (1)
  • UK MHRA · 1 inspection · last May 6, 2015
People (3)
Jennifer Gross, MS
Person
Brian D. Nicholson
Person
Vioela J. Caze
Person
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Avista Pharma Solutions, Inc.
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CHRI Laboratories, Inc.
Company Information

Name

Fresenius Kabi USA, LLC

FEI Number

1000115163

Address

Cornell Avenue, Melrose Park, IL 60160-1002, United States

Country

United States

ID: 1fd32611-ab9e-438a-9ee6-59d3a913d3a3

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