CKD Bio Corp.
⚠️ Moderate Risk
FEI: 3003807288 • Seoul • SOUTH KOREA
FEI Number
3003807288
Location
Seoul
Country
SOUTH KOREAAddress
368 Chungjungro-3A, Seodaemun-Gu, , Seoul, , South Korea
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
NO PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
LIST INGRE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
DIETARYLBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.
LACKS FIRM
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.
NO ENGLISH
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/27/2003 | 54ACC13VITAMIN C (ASCORBIC ACID) | Baltimore District Office (BLT-DO) | |
| 2/26/2003 | 29CCE04MIXED DRINKS (NONALCOHOLIC BEVERAGES) | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 2/26/2003 | 29CCE04MIXED DRINKS (NONALCOHOLIC BEVERAGES) | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 2/26/2003 | 29CCE04MIXED DRINKS (NONALCOHOLIC BEVERAGES) | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 2/26/2003 | 29CCE04MIXED DRINKS (NONALCOHOLIC BEVERAGES) | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 2/26/2003 | 29CCE04MIXED DRINKS (NONALCOHOLIC BEVERAGES) | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is CKD Bio Corp.'s FDA import refusal history?
CKD Bio Corp. (FEI: 3003807288) has 6 FDA import refusal record(s) in our database, spanning from 2/26/2003 to 10/27/2003.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. CKD Bio Corp.'s FEI number is 3003807288.
What types of violations has CKD Bio Corp. received?
CKD Bio Corp. has been cited for 6 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about CKD Bio Corp. come from?
All FDA import refusal data for CKD Bio Corp. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.