Samsung Bioepis Co. Ltd.
FDA inspection history across 2 sites, 2023 to 2024
- 2
- Form 483s
Every document, by year
- Form 483
2023: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2023–24Two Form 483s, at Yeonsu, South Korea and Incheon, South Korea.
- 2024The longest 483 on file: 2 observations over 4 pages at Incheon, South Korea.
Cited most
Across all Samsung Bioepis Co. observations on file
- 21 CFR 211.198Complaint files1
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 312.50General responsibilities of sponsors1
- 21 CFR 600.80(c)(1)(iii)Postmarketing reporting of adverse experiences1
The complete Samsung Bioepis Co. file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Incheon, South Korea
One Form 483 · 2024 · 2 observations
Latest: Form 483, Nov 22, 2024 →Yeonsu, South Korea
One Form 483 · 2023 · 2 observations
Latest: Form 483, Sep 15, 2023 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-11-22 | 483 Form 483 | Incheon, South Korea | 2 | $99 |
| 2023-09-15 | 483 Form 483 | Yeonsu, South Korea | 2 | $99 |
Investigators on these documents
FEI number 3010031951 · most recent document Nov 22, 2024
About Samsung Bioepis Co. Ltd.
How many FDA Form 483s has Samsung Bioepis Co. Ltd. received?
FDA Intel has 2 Form 483s on file for Samsung Bioepis Co. Ltd.; the most recent is dated Nov 22, 2024.
When was Samsung Bioepis Co. Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Samsung Bioepis Co. Ltd. is a Form 483 dated Nov 22, 2024, for the site in Incheon, South Korea.
What did FDA cite at Samsung Bioepis Co. Ltd.?
The regulations cited most in the observations on file for Samsung Bioepis Co. Ltd. are 21 CFR 211.198 (Complaint files), 1 time; 21 CFR 211.22 (Responsibilities of quality control unit), 1 time; 21 CFR 312.50 (General responsibilities of sponsors), 1 time.