Hanlim Pharm. Co., Ltd.
FDA inspection history across 2 sites, 2018 to 2026
- 2
- Close-outs
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Warning letter
- Close-out
- Form 483
2018: one close-out letter and one Form 483; 2022: one close-out letter and one Form 483; 2026: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2018One close-out letter and one Form 483, at Yonginsi Ceoin-gu, South Korea.
- 2018The longest 483 on file: 7 observations over 8 pages at Yonginsi Ceoin-gu, South Korea.
- 2022One close-out letter and one Form 483, at Yongin-si, South Korea.
- 2026One warning letter.
Cited most
Across all Hanlim Pharm. Co. observations on file
- 21 CFR 211.68(b)Automatic, mechanical, and electronic equipment3
- 21 CFR 211.113(b)Control of microbiological contamination2
- 21 CFR 211.160(a)General requirements2
- 21 CFR 111
- 21 CFR 211.25(a)Personnel qualifications1
The complete Hanlim Pharm. Co. file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Yongin-si, South Korea
One Form 483 · 2022 · 2 observations
Latest: Form 483, May 31, 2022 →Yonginsi Ceoin-gu, South Korea
One Form 483 · 2018 · 7 observations
Latest: Form 483, Feb 6, 2018 →
Also: three documents not tied to a site.
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-10-02 | Warning letter Warning letter | — | — | $99 |
| 2022-08-25 | Close-out Close-out letter | — | — | $99 |
| 2022-05-31 | 483 Form 483 | Yongin-si, South Korea | 2 | $99 |
| 2018-10-03 | Close-out Close-out letter | — | — | $99 |
| 2018-02-06 | 483 Form 483 | Yonginsi Ceoin-gu, South Korea | 7 | $99 |
Investigators on these documents
FEI number 3004886113 · most recent document Oct 2, 2026
About Hanlim Pharm. Co., Ltd.
How many FDA Form 483s has Hanlim Pharm. Co., Ltd. received?
FDA Intel has 2 Form 483s on file for Hanlim Pharm. Co., Ltd.; the most recent is dated May 31, 2022.
When was Hanlim Pharm. Co., Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Hanlim Pharm. Co., Ltd. is a Form 483 dated May 31, 2022, for the site in Yongin-si, South Korea.
What did FDA cite at Hanlim Pharm. Co., Ltd.?
The regulations cited most in the observations on file for Hanlim Pharm. Co., Ltd. are 21 CFR 211.68(b) (Automatic, mechanical, and electronic equipment), 3 times; 21 CFR 211.113(b) (Control of microbiological contamination), 2 times; 21 CFR 211.160(a) (General requirements), 2 times.
Has Hanlim Pharm. Co., Ltd. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Hanlim Pharm. Co., Ltd.; the most recent is dated Oct 2, 2026.