Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-11-05.
At a glance
Inspections
3
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Oct 2025 – 5 Nov 2025 | Human Drugs | 483 | View 483 → |
| 30 Jan 2023 – 6 Mar 2023 | Human Drugs | 483 | View 483 → |
| 7 Nov 2018 – 4 Dec 2018 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
5 Nov 2025
21 CFR 211.110(b)
In-process conformity - examination, sample testing
Cited by Jonathan G Matrisciano, Daniel L Zheng, Lori M Newman
5 Nov 2025
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Jonathan G Matrisciano, Daniel L Zheng, Lori M Newman
5 Nov 2025
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Jonathan G Matrisciano, Daniel L Zheng, Lori M Newman
5 Nov 2025
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Jonathan G Matrisciano, Daniel L Zheng, Lori M Newman
5 Nov 2025
21 CFR 211.42(c)(10)(iv)
Environmental Monitoring System
Cited by Jonathan G Matrisciano, Daniel L Zheng, Lori M Newman
Investigators
FDA investigators tied to this site in the record.
Jonathan G Matrisciano2 insp.
Daniel L Zheng1 insp.
Lori M Newman1 insp.
John P Mistler1 insp.
Sean R Marcsisin1 insp.
Erik W Koester1 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 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(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 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.94(b) | Cited across public-safe Form 483 observations | 1x |
| FDCA 503B(a)(10) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Fresenius Kabi Compounding, LLC's 3 Form 483s
Source PDFs 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