SOUTH KOREA
SOUTH KORE
FDA import refusal data for products from SOUTH KOREA
Common Violations
Top Firms
| # | Firm Name | Risk | Refusals |
|---|---|---|---|
| 1 | DreamCon Co. Ltd. Yangsan | Risk: 81.2 | 565 |
| 2 | Risk: 83.2 | 343 | |
| 3 | Bescon Co., Ltd. Cheonan-City | Risk: 64.8 | 340 |
| 4 | Risk: 77.8 | 188 | |
| 5 | Kolmar Korea Co., Ltd. - Gwanjeong Factory Chungcheongnam-Do | Risk: 78.3 | 149 |
| 6 | Risk: 78.4 | 141 | |
| 7 | Interojo Inc. Pyeongtaek City | Risk: 73.9 | 139 |
| 8 | COSMAX, INC. Hwaseong-si | Risk: 77.4 | 111 |
| 9 | Samyang Foods Co Ltd Seoul | Risk: 55.0 | 107 |
| 10 | Cosmecca Korea Co., Ltd. Eumseong | Risk: 82.3 | 106 |
| 11 | Risk: 57.4 | 103 | |
| 12 | Maeil Dairies Co., Ltd- GWANGJU PLANT Gwangsan-Ku | Risk: 64.4 | 103 |
| 13 | Seoul Cosmetics Co., Ltd. Namdong District | Risk: 86.0 | 102 |
| 14 | Risk: 63.2 | 102 | |
| 15 | Lensmam Co. Ltd Gyeonggi-do | Risk: 70.1 | 98 |
| 16 | Risk: 61.4 | 98 | |
| 17 | AMORE PACIFIC CORPORATION Yongsan | Risk: 56.8 | 90 |
| 18 | PUREPLUS CO., LTD Hamyang | Risk: 66.2 | 71 |
| 19 | Kolmar Korea Co. Ltd. Sejong | Risk: 74.5 | 64 |
| 20 | Okf Corporation Sung Nam City | Risk: 59.8 | 62 |
Frequently Asked Questions
How many FDA import refusals are from SOUTH KOREA?
According to FDA records, there have been 13,816 import refusals for products originating from SOUTH KOREA, involving 3353 firms.
What products from SOUTH KOREA are commonly refused by the FDA?
Products from SOUTH KOREA may be refused for various reasons including adulteration, misbranding, lack of proper registration, or failure to meet U.S. safety standards. The specific products vary by firm and time period. View the common violations section on this page for more details.
Does an import refusal mean products from SOUTH KOREA are unsafe?
Not necessarily. An import refusal indicates a specific shipment appeared to violate FDA requirements at the time of inspection. Many SOUTH KOREA firms successfully import products that meet all FDA requirements. Import refusals help identify and prevent non-compliant products from entering the U.S. market.
How current is the FDA import refusal data for SOUTH KOREA?
Our database includes FDA import refusals for SOUTH KOREA through 1/22/2026. Data is sourced from the FDA Data Dashboard and updated monthly.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.