STgen Bio Co., Ltd.
Form 483 issued June 25, 2024 · Incheon, South Korea
- Investigators
- Jeanne Fringer· Yiwei Li
- Observations
- 8
- Pages
- 11
- FEI number
- 3025416433
In short: On June 25, 2024, FDA issued a Form 483 with 8 observations to STgen Bio Co., Ltd. in Incheon, South Korea (FEI 3025416433). The investigators were Jeanne Fringer and Yiwei Li. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and quality system account for 5 of 8 observations.
Most cited: 21 CFR 211.100 (2×) · 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 02
Written procedures for production and process controls designed to assure that the drug product has the…
- 03
Failure to thoroughly review high rates…
- 04
There is a lack of assurance that your manufacturing operations in the drug substance production area…
This inspection in context
Jeanne Fringer
6 documents · 2021–2025
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in California.
The firmSTgen Bio Co., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at STgen Bio Co., Ltd.?
FDA listed 8 observations on this Form 483, mostly about production, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected STgen Bio Co., Ltd.?
Jeanne Fringer and Yiwei Li are named on this Form 483. Each investigator has a profile showing what they cite most.
When was STgen Bio Co., Ltd. inspected by FDA?
This Form 483 is dated June 25, 2024.
How do I get the full Form 483 for STgen Bio 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.