Il Hwa Co., Ltd
⚠️ Moderate Risk
FEI: 3011431462 • Chaungchongbuk-Do • SOUTH KOREA
FEI Number
3011431462
Location
Chaungchongbuk-Do
Country
SOUTH KOREAAddress
125, Chojung-Ri, Naesu-Eupchungwon-Kun, , Chaungchongbuk-Do, , 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.
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.
LACKS N/C
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)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
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)).
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/14/2008 | 24WHE99LEAF AND STEM VEGETABLES, JUICE OR DRINK, N.E.C. | 83NO PROCESS | San Francisco District Office (SAN-DO) |
| 7/7/2008 | 24WHE99LEAF AND STEM VEGETABLES, JUICE OR DRINK, N.E.C. | 83NO PROCESS | San Francisco District Office (SAN-DO) |
| 2/18/2003 | 29YGY99SOFT DRINKS AND WATERS NOT MENTIONED ELSEWHERE, N.E.C. | 11UNSAFE COL | Los Angeles District Office (LOS-DO) |
| 5/22/2002 | 29CGT03CIDER (NONALCOHOLIC BEVERAGES) | Los Angeles District Office (LOS-DO) | |
| 4/9/2002 | 29CGE03CIDER (NONALCOHOLIC BEVERAGES) | Los Angeles District Office (LOS-DO) | |
| 4/9/2002 | 29CGE03CIDER (NONALCOHOLIC BEVERAGES) | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Il Hwa Co., Ltd's FDA import refusal history?
Il Hwa Co., Ltd (FEI: 3011431462) has 6 FDA import refusal record(s) in our database, spanning from 4/9/2002 to 7/14/2008.
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. Il Hwa Co., Ltd's FEI number is 3011431462.
What types of violations has Il Hwa Co., Ltd received?
Il Hwa Co., Ltd 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 Il Hwa Co., Ltd come from?
All FDA import refusal data for Il Hwa Co., Ltd 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.