Overview
- 8 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-02-13.
At a glance
Inspections
8
Form 483s
6
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Feb 2026 – 13 Feb 2026 | Human Drugs | 483 | On file |
| 30 Jan 2024 – 8 Feb 2024 | Medical Devices & Rad Health | 483 | On file |
| 5 Jun 2023 – 13 Jun 2023 | Human Drugs | 483 | View 483 → |
| 28 Jan 2019 – 5 Feb 2019 | Human Drugs | 483 | On file |
| 17 Aug 2017 – 18 Aug 2017 | Medical Devices & Rad Health | Clean | |
| 20 Jun 2016 – 24 Jun 2016 | Human Drugs | 483 | View 483 → |
| 2 Apr 2014 – 4 Apr 2014 | Human Drugs | Clean | |
| 2 Nov 2012 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
13 Jun 2023
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Veronica Fuentes, Gretchen M Laws, Brittny C Cargo
13 Jun 2023
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Veronica Fuentes, Gretchen M Laws, Brittny C Cargo
13 Jun 2023
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Veronica Fuentes, Gretchen M Laws, Brittny C Cargo
13 Jun 2023
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Veronica Fuentes, Gretchen M Laws, Brittny C Cargo
13 Jun 2023
21 CFR 211.188(b)(12)
Documentation of Batch Investigations
Cited by Veronica Fuentes, Gretchen M Laws, Brittny C Cargo
Investigators
FDA investigators tied to this site in the record.
Yvins Dezan1 insp.
Ankur C Patel1 insp.
Karishma G Gopaul1 insp.
Inga M Warr1 insp.
Veronica Fuentes1 insp.
Gretchen M Laws1 insp.
Brittny C Cargo1 insp.
Christopher S Keating1 insp.
Samuel L Murray1 insp.
Seneca D Toms1 insp.
Kara D Dobbin1 insp.
Viviana Matta1 insp.
Jason F Chancey1 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 | 4x |
| 21 CFR 211.188(b)(12) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.130(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Fresenius Kabi USA, LLC's 6 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