Dong-A Otsuka Co., Ltd
⚠️ Moderate Risk
FEI: 3009855751 • Kyungki • SOUTH KOREA
FEI Number
3009855751
Location
Kyungki
Country
SOUTH KOREAAddress
450-1 Suksu Anyang, , Kyungki, , 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
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).
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.
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.
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.
YELLOW #5
The food appears to bear or contain the color additive FD & C Yellow No. 5, which is not declared on the label per 21 CFR 74.705(a)(c) under section 721.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/7/2013 | 29AEE99NONCARBONATED SOFT DRINK, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 5/2/2005 | 29BET07SOFT DRINK, SUBTROPICAL OR TROPICAL FRUIT FLAVORED, CARBONATED | 64YELLOW #5 | Los Angeles District Office (LOS-DO) |
| 5/2/2005 | 29BET01SOFT DRINK, BERRY FRUIT FLAVORED, CARBONATED | 11UNSAFE COL | Los Angeles District Office (LOS-DO) |
| 5/2/2005 | 29BET02SOFT DRINK, CITRUS FRUIT FLAVORED, CARBONATED | 11UNSAFE COL | Los Angeles District Office (LOS-DO) |
| 1/31/2005 | 29BHE99CARBONATED SOFT DRINK, N.E.C. | 11UNSAFE COL | Los Angeles District Office (LOS-DO) |
| 3/29/2002 | 29AET01SOFT DRINK, BERRY FRUIT FLAVORED, NONCARBONATED | 11UNSAFE COL | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Dong-A Otsuka Co., Ltd's FDA import refusal history?
Dong-A Otsuka Co., Ltd (FEI: 3009855751) has 6 FDA import refusal record(s) in our database, spanning from 3/29/2002 to 3/7/2013.
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. Dong-A Otsuka Co., Ltd's FEI number is 3009855751.
What types of violations has Dong-A Otsuka Co., Ltd received?
Dong-A Otsuka 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 Dong-A Otsuka Co., Ltd come from?
All FDA import refusal data for Dong-A Otsuka 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.