Overview
- 7 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-11-22.
At a glance
Inspections
7
Form 483s
3
EIRs
3
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 20 Nov 2024 – 22 Nov 2024 | Human Drugs | 483 | On file |
| 4 Sep 2023 – 15 Sep 2023 | Human Drugs | 483 | View 483 → |
| 11 Feb 2019 – 15 Feb 2019 | Human Drugs | Clean | |
| 12 Nov 2018 – 14 Nov 2018 | Human Drugs | Clean | |
| 5 Mar 2018 – 7 Mar 2018 | Human Drugs | Clean | |
| 2 Nov 2017 – 6 Nov 2017 | Human Drugs | Clean | |
| 16 Aug 2016 – 19 Aug 2016 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
15 Sep 2023
21 CFR 600.80(c)(1)(iii)
Reporting Requirements - submission of reports
Cited by Scott N Lim
Investigators
FDA investigators tied to this site in the record.
Thuy T Nguyen2 insp.
Rajiv R Srivastava1 insp.
Scott N Lim1 insp.
Seneca D Toms1 insp.
Viviana Matta1 insp.
Frances Namuswe1 insp.
Tracy A Denison1 insp.
Juan R Jimenez Garcia1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 312.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 600.80(c)(1)(iii) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Samsung Bioepis Co., Ltd.'s 3 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