Binex 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 Binex Co. observations on file
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.160General requirements1
- 21 CFR 211.192Production record review1
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 211.68Automatic, mechanical, and electronic equipment1
The complete Binex Co. file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Incheon, South Korea
One Form 483 · 2024 · 4 observations
Latest: Form 483, Jun 20, 2024 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-06-20 | 483 Form 483 | Incheon, South Korea | 4 | $99 |
Investigators on these documents
Aditi S. Thakur (1)Della Shin (1)Thuy T. Nguyen (1)Zachary Kraus (1)
FEI number 3014475240 · most recent document Jun 20, 2024
About Binex Co., Ltd.
How many FDA Form 483s has Binex Co., Ltd. received?
FDA Intel has 1 Form 483 on file for Binex Co., Ltd.; the most recent is dated Jun 20, 2024.
When was Binex Co., Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Binex Co., Ltd. is a Form 483 dated Jun 20, 2024, for the site in Incheon, South Korea.
What did FDA cite at Binex Co., Ltd.?
The regulations cited most in the observations on file for Binex Co., Ltd. are 21 CFR 211.113 (Control of microbiological contamination), 1 time; 21 CFR 211.160 (General requirements), 1 time; 21 CFR 211.192 (Production record review), 1 time.