STgen Bio Co., Ltd.
FDA inspection history in Incheon, South Korea, 2024
- 1
- Form 483
Every document, by year
- Form 483
2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2024One Form 483, at Incheon, South Korea.
Cited most
Across all STgen Bio Co. observations on file
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.160General requirements2
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.192Production record review1
- 21 CFR 211.22Responsibilities of quality control unit1
The complete STgen Bio Co. file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Incheon, South Korea
One Form 483 · 2024
Latest: Form 483, Jun 25, 2024 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-06-25 | 483 Form 483 | Incheon, South Korea | — | $99 |
Investigators on these documents
FEI number 3025416433 · most recent document Jun 25, 2024
About STgen Bio Co., Ltd.
How many FDA Form 483s has STgen Bio Co., Ltd. received?
FDA Intel has 1 Form 483 on file for STgen Bio Co., Ltd.; the most recent is dated Jun 25, 2024.
When was STgen Bio Co., Ltd. last inspected by FDA?
The most recent FDA inspection document on file for STgen Bio Co., Ltd. is a Form 483 dated Jun 25, 2024, for the site in Incheon, South Korea.
What did FDA cite at STgen Bio Co., Ltd.?
The regulations cited most in the observations on file for STgen Bio Co., Ltd. are 21 CFR 211.100 (Written procedures; deviations), 2 times; 21 CFR 211.160 (General requirements), 2 times; 21 CFR 211.113 (Control of microbiological contamination), 1 time.