Yuhan Chemical, Inc.
FDA inspection history in Ansan-si, South Korea, 2017
- 1
- Form 483
Every document, by year
- Form 483
2017: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017One Form 483, at Ansan-si, South Korea.
Cited most
Across all Yuhan Chemical observations on file
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.192Production record review1
- 21 CFR 211.198Complaint files1
The complete Yuhan Chemical file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Ansan-si, South Korea
One Form 483 · 2017 · 6 observations
Latest: Form 483, Sep 22, 2017 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2017-09-22 | 483 Form 483 | Ansan-si, South Korea | 6 | $99 |
FEI number 3004015296 · most recent document Sep 22, 2017
About Yuhan Chemical, Inc.
How many FDA Form 483s has Yuhan Chemical, Inc. received?
FDA Intel has 1 Form 483 on file for Yuhan Chemical, Inc.; the most recent is dated Sep 22, 2017.
When was Yuhan Chemical, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Yuhan Chemical, Inc. is a Form 483 dated Sep 22, 2017, for the site in Ansan-si, South Korea.
What did FDA cite at Yuhan Chemical, Inc.?
The regulations cited most in the observations on file for Yuhan Chemical, Inc. are 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times; 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 1 time.