Fresenius Kabi USA, LLC
FDA inspection history in Grand Island, New York, 2011 to 2026
- 10
- Form 483s
Every document, by year
- Form 483
2011: one Form 483; 2014: one Form 483; 2015: one Form 483; 2016: one Form 483; 2017: one Form 483; 2018: one Form 483; 2019: one Form 483; 2023: two Form 483s; 2026: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2011One Form 483, at Grand Island, New York.
- 2011The longest 483 on file: 16 observations over 18 pages at Grand Island, New York.
- 2014–19Six Form 483s, at Grand Island, New York.
- 2023Two Form 483s, at Grand Island, New York.
- 2026One Form 483, at Grand Island, New York.
Cited most
Across all Fresenius Kabi USA observations on file
- 21 CFR 211.113Control of microbiological contamination5
- 21 CFR 211.192Production record review5
- 21 CFR 211.100Written procedures; deviations3
- 21 CFR 211.160General requirements2
- 21 CFR 211.186Master production and control records2
The complete Fresenius Kabi USA file.
All 10 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
25% off buying them one by one
Sites
Grand Island, New York
Ten Form 483s · 2011 to 2026 · 40 observations
Latest: Form 483, May 14, 2026 →
Documents
10 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-05-14 | 483 Form 483 | Grand Island, New York | 2 | $99 |
| 2023-10-13 | 483 Form 483 | Grand Island, New York | 2 | $99 |
| 2023-08-30 | 483 Form 483 | Grand Island, New York | 1 | $99 |
| 2019-08-12 | 483 Form 483 | Grand Island, New York | 2 | $99 |
| 2018-06-29 | 483 Form 483 | Grand Island, New York | 6 | $99 |
| 2017-03-30 | 483 Form 483 | Grand Island, New York | 1 | $99 |
| 2016-02-04 | 483 Form 483 | Grand Island, New York | 5 | $99 |
| 2015-03-06 | 483 Form 483 | Grand Island, New York | 2 | $99 |
| 2014-10-24 | 483 Form 483 | Grand Island, New York | 3 | $99 |
| 2011-07-08 | 483 Form 483 | Grand Island, New York | 16 | $99 |
Investigators on these documents
James D. Bridges (3)Sony Mathews (2)Mindy M. Chou (2)Jazmine N. Brown (1)Johnna L. Bleem (1)Joshrenzo N. Ramilo (1)Kevin A. Gonzalez (1)Matthew D. Schnittker (1)Patric C. Klotzbuecher (1)Alice S. Tsao (1)William Leonard (1)Charanjeet S. Jassal (1)
FEI number 3001833549 · most recent document May 14, 2026
About Fresenius Kabi USA, LLC
How many FDA Form 483s has Fresenius Kabi USA, LLC received?
FDA Intel has 10 Form 483s on file for Fresenius Kabi USA, LLC; the most recent is dated May 14, 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 May 14, 2026, for the site in Grand Island, New York.
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), 5 times; 21 CFR 211.192 (Production record review), 5 times; 21 CFR 211.100 (Written procedures; deviations), 3 times.