Overview
- 6 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-07-23.
At a glance
Inspections
6
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 15 Jul 2024 – 23 Jul 2024 | Human Drugs | 483 | On file |
| 11 Sep 2023 – 14 Sep 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 12 Jun 2023 – 16 Jun 2023 | Human Drugs | Clean | |
| 6 Jan 2020 – 10 Jan 2020 | Human Drugs | Clean | |
| 8 Jul 2019 – 12 Jul 2019 | Human Drugs | Clean | |
| 13 Nov 2017 – 17 Nov 2017 | Human Drugs | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
14 Sep 2023
21 CFR 820.20(c)
Management review - Lack of or inadequate procedures
Cited by Thai T Duong
Investigators
FDA investigators tied to this site in the record.
Robert J Ham1 insp.
Thai T Duong1 insp.
Michael Shanks1 insp.
Ariel Cruz Figueroa1 insp.
Michael P Sheehan1 insp.
Edmund F Mrak1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind CELLTRION PHARM, 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