Samsung Biologics Co., Ltd.
FDA inspection history across 4 sites, 2016 to 2025
- 14
- Form 483s
Every document, by year
- Form 483
2016: one Form 483; 2017: one Form 483; 2018: three Form 483s; 2019: two Form 483s; 2021: one Form 483; 2022: one Form 483; 2023: two Form 483s; 2024: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–2513 Form 483s, at Incheon, South Korea; Yeonsu-gu, South Korea and Yeonsu Incheon, South Korea.
- 2016The longest 483 on file: 13 observations over 10 pages at Incheon, South Korea.
Cited most
Across all Samsung Biologics Co. observations on file
- 21 CFR 211.160General requirements9
- 21 CFR 211.67Equipment cleaning and maintenance8
- 21 CFR 211.113Control of microbiological contamination7
- 21 CFR 211.192Production record review6
- 21 CFR 211.22Responsibilities of quality control unit4
The complete Samsung Biologics Co. file.
All 14 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
25% off buying them one by one
Sites
Incheon, South Korea
11 Form 483s · 2016 to 2024 · 46 observations
Latest: Form 483, Jul 30, 2024 →Yeonsu Incheon, South Korea
One Form 483 · 2025
Latest: Form 483, May 27, 2025 →Yeonsu-gu, South Korea
One Form 483 · 2017 · 4 observations
Latest: Form 483, Jul 25, 2017 →Y consu-gu, South Korea
One Form 483
Latest: Form 483, — →
Documents
14 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-05-27 | 483 Form 483 | Yeonsu Incheon, South Korea | — | $99 |
| 2024-07-30 | 483 Form 483 | Incheon, South Korea | 6 | $99 |
| 2023-09-01 | 483 Form 483 | Incheon, South Korea | 6 | $99 |
| 2023-02-28 | 483 Form 483 | Incheon, South Korea | 3 | $99 |
| 2022-06-09 | 483 Form 483 | Incheon, South Korea | 3 | $99 |
| 2021-08-24 | 483 Form 483 | Incheon, South Korea | 1 | $99 |
| 2019-11-01 | 483 Form 483 | Incheon, South Korea | 1 | $99 |
| 2019-09-10 | 483 Form 483 | Incheon, South Korea | 3 | $99 |
| 2018-06-26 | 483 Form 483 | Incheon, South Korea | 3 | $99 |
| 2018-05-11 | 483 Form 483 | Incheon, South Korea | 5 | $99 |
| 2018-03-14 | 483 Form 483 | Incheon, South Korea | 2 | $99 |
| 2017-07-25 | 483 Form 483 | Yeonsu-gu, South Korea | 4 | $99 |
| 2016-06-22 | 483 Form 483 | Incheon, South Korea | 13 | $99 |
| Undated | 483 Form 483 | Y consu-gu, South Korea | — | $99 |
Investigators on these documents
Deborah Schmiel (2)C. Ward (1)Chen Sun (1)Dae Totus (1)Diane Raccasi (1)Laurel A. Beer (1)Lucila B. Nwatu (1)Madushini Dharmasena (1)Maria J. Lopez-Barragan (1)Maria Teresa Gutierroz-Lugo (1)Marion Michaelis (1)Matthew B. Casale (1)
FEI number 3010479596 · most recent document May 27, 2025
About Samsung Biologics Co., Ltd.
How many FDA Form 483s has Samsung Biologics Co., Ltd. received?
FDA Intel has 14 Form 483s on file for Samsung Biologics Co., Ltd.; the most recent is dated May 27, 2025.
When was Samsung Biologics Co., Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Samsung Biologics Co., Ltd. is a Form 483 dated May 27, 2025, for the site in Yeonsu Incheon, South Korea.
What did FDA cite at Samsung Biologics Co., Ltd.?
The regulations cited most in the observations on file for Samsung Biologics Co., Ltd. are 21 CFR 211.160 (General requirements), 9 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 8 times; 21 CFR 211.113 (Control of microbiological contamination), 7 times.