Kolmar Korea Co., Ltd.
FDA inspection history in Sejong-Si, South Korea, 2022 to 2024
- 2
- Form 483s
Every document, by year
- Form 483
2022: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022–24Two Form 483s, at Sejong-Si, South Korea.
- 2024The longest 483 on file: 6 observations over 7 pages at Sejong-Si, South Korea.
Cited most
Across all Kolmar Korea Co. observations on file
- 21 CFR 211.160(b)General requirements2
- 21 CFR 211.130(c)Packaging and labeling operations1
- 21 CFR 211.142Warehousing procedures1
- 21 CFR 211.166(b)Stability testing1
- 21 CFR 211.188(b)Batch production and control records1
The complete Kolmar Korea 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
Sejong-Si, South Korea
Two Form 483s · 2022 to 2024 · 7 observations
Latest: Form 483, Feb 16, 2024 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-02-16 | 483 Form 483 | Sejong-Si, South Korea | 6 | $99 |
| 2022-07-07 | 483 Form 483 | Sejong-Si, South Korea | 1 | $99 |
Investigators on these documents
FEI number 3010299845 · most recent document Feb 16, 2024
About Kolmar Korea Co., Ltd.
How many FDA Form 483s has Kolmar Korea Co., Ltd. received?
FDA Intel has 2 Form 483s on file for Kolmar Korea Co., Ltd.; the most recent is dated Feb 16, 2024.
When was Kolmar Korea Co., Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Kolmar Korea Co., Ltd. is a Form 483 dated Feb 16, 2024, for the site in Sejong-Si, South Korea.
What did FDA cite at Kolmar Korea Co., Ltd.?
The regulations cited most in the observations on file for Kolmar Korea Co., Ltd. are 21 CFR 211.160(b) (General requirements), 2 times; 21 CFR 211.130(c) (Packaging and labeling operations), 1 time; 21 CFR 211.142 (Warehousing procedures), 1 time.