Overview
- 6 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-09-19.
At a glance
Inspections
6
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 15 Sep 2025 – 19 Sep 2025 | Human Drugs | Clean | |
| 16 Oct 2024 – 18 Oct 2024 | Medical Devices & Rad Health | Clean | |
| 5 Dec 2022 – 7 Dec 2022 | Medical Devices & Rad Health | Clean | |
| 22 Jun 2020 – 26 Jun 2020 | Human Drugs | 483 | On file |
| 9 Sep 2019 – 12 Sep 2019 | Human Drugs | Clean | |
| 2 Oct 2017 – 6 Oct 2017 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
6 Oct 2017
21 CFR 211.160(a)
Deviations from laboratory control requirements
Cited by Brandon C Heitmeier
6 Oct 2017
21 CFR 211.160(a)
Deviations from laboratory control requirements
Cited by Brandon C Heitmeier
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Fresenius USA Manufacturing, Inc's 2 Form 483s
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