Samsung Bioepis Co. Ltd.
Form 483 issued September 15, 2023 · Yeonsu, South Korea
- Inspection
- Sep 4 – Sep 15, 2023
- Investigator
- Scott N. Lim
- Observations
- 2
- Pages
- 2
- FEI number
- 3010031951
In short: On September 15, 2023, FDA issued a Form 483 with 2 observations to Samsung Bioepis Co. Ltd. in Yeonsu, South Korea (FEI 3010031951) after an inspection that ran Sep 4 – Sep 15, 2023. The investigator was Scott N. Lim. Most observations concern clinical (BIMO) and biologics CGMP; the most-cited regulation is 21 CFR 312.50 (general responsibilities of sponsors).
At a glance
Clinical (BIMO) and biologics cgmp account for 2 of 2 observations.
Most cited: 21 CFR 312.50 (1×) · 600.80(c)(1)(iii) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Failure to ensure proper monitoring of the study, ensure the study is conducted in accordance with…
- 02
Failure to submit each post marketing 15-day alert and post marketing 15-day alert follow…
This inspection in context
Scott N. Lim
14 documents · 2019–2026
Cites 211.165(a) (testing and release for distribution) more than any other section. Most of their documents are for sites in California.
The firmSamsung Bioepis Co. Ltd. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 312.50
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Samsung Bioepis Co. Ltd.?
FDA listed 2 observations on this Form 483, mostly about clinical (BIMO) and biologics CGMP. The most-cited regulation is 21 CFR 312.50 (general responsibilities of sponsors). The opening words of each observation are shown on this page.
Who inspected Samsung Bioepis Co. Ltd.?
Scott N. Lim is named on this Form 483, for the inspection of Sep 4 – Sep 15, 2023. Each investigator has a profile showing what they cite most.
When was Samsung Bioepis Co. Ltd. inspected by FDA?
The inspection ran Sep 4 – Sep 15, 2023, and the Form 483 is dated September 15, 2023.
How do I get the full Form 483 for Samsung Bioepis Co. Ltd.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.