Overview
- 25 FDA inspections are on record.
- 17 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-14.
At a glance
Inspections
25
Form 483s
17
EIRs
6
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 5 May 2026 – 14 May 2026 | Human Drugs | 483 | View 483 → |
| 4 Oct 2023 – 13 Oct 2023 | Human Drugs | 483 | View 483 → |
| 28 Aug 2023 – 30 Aug 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 25 Jul 2019 – 12 Aug 2019 | Human Drugs | 483 | View 483 → |
| 25 Jun 2018 – 29 Jun 2018 | Human Drugs | 483 | On file |
| 21 Mar 2017 – 30 Mar 2017 | Human Drugs | 483 | On file |
| 26 Jan 2017 – 1 Feb 2017 | Human Drugs | 483 | On file |
| 27 Jan 2016 – 4 Feb 2016 | Human Drugs | 483 | View 483 → |
| 24 Feb 2015 – 6 Mar 2015 | Human Drugs | 483 | On file |
| 20 Oct 2014 – 24 Oct 2014 | Human Drugs | 483 | View 483 → |
| 11 Jan 2013 | Not recorded | 483 | View 483 → |
| 29 Aug 2011 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
14 May 2026
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Mindy M Chou, JoshRenzo N Ramilo
14 May 2026
21 CFR 211.194(a)(2)
Laboratory Test Method Verification
Cited by Mindy M Chou, JoshRenzo N Ramilo
13 Oct 2023
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Mindy M Chou, Jazmine N Brown
13 Oct 2023
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Mindy M Chou, Jazmine N Brown
Investigators
FDA investigators tied to this site in the record.
James D Bridges7 insp.
Mindy M Chou3 insp.
Karen L Kosar3 insp.
Kevin A Gonzalez3 insp.
Michael W Burd3 insp.
Sony Mathews2 insp.
Patric C Klotzbuecher2 insp.
Charanjeet Jassal2 insp.
JoshRenzo N Ramilo1 insp.
Jazmine N Brown1 insp.
Matthew D Schnittker1 insp.
Rajiv R Srivastava1 insp.
Marcellinus D Dordunoo1 insp.
Johnna L Bleem1 insp.
William J Leonard1 insp.
Helen B Ricalde1 insp.
Erika E Englund1 insp.
Bijoy Panicker1 insp.
Wendy G Tan1 insp.
Brian J Ryan1 insp.
Alice S Tsao1 insp.
Felix Maldonado1 insp.
Paul C Mouris1 insp.
Harry J Brewer1 insp.
Erin L Nagel1 insp.
Michael A Charles1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 7x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.194(a)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.204 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Fresenius Kabi USA, LLC's 17 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat