Overview
- 4 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-04-09.
At a glance
Inspections
4
Form 483s
2
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 7 Apr 2025 – 9 Apr 2025 | Human Drugs | Clean | |
| 30 May 2023 – 9 Jun 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 9 Nov 2016 | Medical Devices & Rad Health | Clean | |
| 22 Jan 2013 – 15 Feb 2013 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Paige R Mccoy1 insp.
Divek R Jumani1 insp.
Jacqueline S Warner1 insp.
Scott R Izyk1 insp.
Chad N Thompson1 insp.
Catherine M Beer1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 803.50(a)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.50(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.250(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Delcath Systems Inc.'s 2 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