Huons Co., Ltd.
FDA inspection history in Jecheon-si, South Korea, 2019 to 2026
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2019: one Form 483; 2026: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Jecheon-si, South Korea.
- 2026One warning letter.
Cited most
Across all Huons Co. observations on file
- 21 CFR 211.160General requirements2
- 21 CFR 211.192Production record review1
- 21 CFR 211.42Design and construction features1
- 21 CFR 211.68Automatic, mechanical, and electronic equipment1
The complete Huons Co. file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Jecheon-si, South Korea
One Form 483 · 2019 · 5 observations
Latest: Form 483, Oct 18, 2019 →
Also: one document not tied to a site.
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-06-15 | Warning letter Warning letter | — | — | $99 |
| 2019-10-18 | 483 Form 483 | Jecheon-si, South Korea | 5 | $99 |
Investigators on these documents
FEI number 3007163376 · most recent document Jun 15, 2026
About Huons Co., Ltd.
How many FDA Form 483s has Huons Co., Ltd. received?
FDA Intel has 1 Form 483 on file for Huons Co., Ltd.; the most recent is dated Oct 18, 2019.
When was Huons Co., Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Huons Co., Ltd. is a Form 483 dated Oct 18, 2019, for the site in Jecheon-si, South Korea.
What did FDA cite at Huons Co., Ltd.?
The regulations cited most in the observations on file for Huons Co., Ltd. are 21 CFR 211.160 (General requirements), 2 times; 21 CFR 211.192 (Production record review), 1 time; 21 CFR 211.42 (Design and construction features), 1 time.
Has Huons Co., Ltd. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Huons Co., Ltd.; the most recent is dated Jun 15, 2026.