Overview
- 14 FDA inspections are on record.
- 13 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-05-27.
At a glance
Inspections
14
Form 483s
13
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 19 May 2025 – 27 May 2025 | Biologics | 483 | On file |
| 22 Jul 2024 – 30 Jul 2024 | Human Drugs | 483 | On file |
| 21 Aug 2023 – 1 Sep 2023 | Human Drugs | 483 | On file |
| 20 Feb 2023 – 28 Feb 2023 | Biologics | 483 | On file |
| 2 Jun 2022 – 9 Jun 2022 | Human Drugs | 483 | On file |
| 13 Aug 2021 – 24 Aug 2021 | Human Drugs | 483 | On file |
| 24 Oct 2019 – 1 Nov 2019 | Human Drugs | 483 | View 483 → |
| 2 Sep 2019 – 10 Sep 2019 | Human Drugs | 483 | On file |
| 18 Jun 2018 – 26 Jun 2018 | Human Drugs | 483 | View 483 → |
| 7 May 2018 – 11 May 2018 | Human Drugs | 483 | On file |
| 8 Mar 2018 – 14 Mar 2018 | Human Drugs | 483 | On file |
| 17 Jul 2017 – 25 Jul 2017 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
26 Jun 2018
21 CFR 211.25(a)
Training , Education , Experience overall
Cited by Lucila B Nwatu, Deborah H Schmiel
26 Jun 2018
21 CFR 211.25(a)
Training , Education , Experience overall
Cited by Lucila B Nwatu, Deborah H Schmiel
26 Jun 2018
21 CFR 211.63
Equipment Design, Size and Location
Cited by Lucila B Nwatu, Deborah H Schmiel
26 Jun 2018
21 CFR 211.63
Equipment Design, Size and Location
Cited by Lucila B Nwatu, Deborah H Schmiel
Investigators
FDA investigators tied to this site in the record.
Zhong Li2 insp.
Wayne E Seifert2 insp.
Michael Shanks2 insp.
Travis S Bradley1 insp.
Ze Peng1 insp.
Peng Zhou1 insp.
Haarin Chun1 insp.
Yiwei Li1 insp.
Charles Y Kuo1 insp.
Andrea Franco1 insp.
Jeffrey P Raimondi1 insp.
Jacek Cieslak1 insp.
Dogbeda F Mackenzie1 insp.
Hyung-Yul Lee1 insp.
Prabhu P Raju1 insp.
Laurel A Beer1 insp.
Madushini N Dharmasena1 insp.
Yun Wu1 insp.
Matthew B Casale1 insp.
Lucila B Nwatu1 insp.
Deborah H Schmiel1 insp.
Diane L Raccasi1 insp.
Thuy T Nguyen1 insp.
Alicia M Mozzachio1 insp.
Maria J Lopez- Barragan1 insp.
Reyes Candau-Chacon1 insp.
Steven Fong1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Samsung Biologics Co., Ltd.'s 13 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