Fresenius Kabi USA LLC
FDA inspection history across 2 sites, 2013 to 2026
- 6
- Form 483s
- 1
- Warning letter
Every document, by year
- Warning letter
- Form 483
2013: one Form 483; 2015: one Form 483; 2020: one Form 483; 2022: one Form 483; 2023: one Form 483; 2026: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2013–15Two Form 483s, at Melrose Park, Illinois.
- 2020–23Three Form 483s, at Melrose Park, Illinois.
- 2022The longest 483 on file: 6 observations over 15 pages at Melrose Park, Illinois.
- 2026One warning letter and one Form 483, at Melrose Park.
Cited most
Across all Fresenius Kabi USA observations on file
- 21 CFR 211.113Control of microbiological contamination4
- 21 CFR 211.192Production record review3
- 21 CFR 211.22(d)Responsibilities of quality control unit3
- 21 CFR 211.122Materials examination and usage criteria2
- 21 CFR 211.188Batch production and control records2
The complete Fresenius Kabi USA file.
All 7 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Melrose Park, Illinois
Five Form 483s · 2013 to 2023 · 17 observations
Latest: Form 483, Aug 24, 2023 →Melrose Park
One Form 483 · 2026 · 3 observations
Latest: Form 483, Feb 6, 2026 →
Also: one document not tied to a site.
Documents
7 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-09-22 | Warning letter Warning letter | — | — | $99 |
| 2026-02-06 | 483 Form 483 | Melrose Park | 3 | $99 |
| 2023-08-24 | 483 Form 483 | Melrose Park, Illinois | 1 | $99 |
| 2022-06-30 | 483 Form 483 | Melrose Park, Illinois | 6 | $99 |
| 2020-05-18 | 483 Form 483 | Melrose Park, Illinois | 6 | $99 |
| 2015-09-01 | 483 Form 483 | Melrose Park, Illinois | 1 | $99 |
| 2013-12-11 | 483 Form 483 | Melrose Park, Illinois | 3 | $99 |
Investigators on these documents
Brian D. Nicholson (1)Chad W. Rice (1)Christopher D. Leach (1)Claude Garay (1)Joohi Castelvetere (1)Michele L. Glendenning (1)Nicholas J. Presto (1)Robert J. Ham (1)Russell K. Riley (1)
FEI number 1450022 · most recent document Sep 22, 2026
About Fresenius Kabi USA LLC
How many FDA Form 483s has Fresenius Kabi USA LLC received?
FDA Intel has 6 Form 483s on file for Fresenius Kabi USA LLC; the most recent is dated Feb 6, 2026.
When was Fresenius Kabi USA LLC last inspected by FDA?
The most recent FDA inspection document on file for Fresenius Kabi USA LLC is a Form 483 dated Feb 6, 2026, for the site in Melrose Park.
What did FDA cite at Fresenius Kabi USA LLC?
The regulations cited most in the observations on file for Fresenius Kabi USA LLC are 21 CFR 211.113 (Control of microbiological contamination), 4 times; 21 CFR 211.192 (Production record review), 3 times; 21 CFR 211.22(d) (Responsibilities of quality control unit), 3 times.
Has Fresenius Kabi USA LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Fresenius Kabi USA LLC; the most recent is dated Sep 22, 2026.