Binggrae Co. Ltd.
⚠️ Moderate Risk
FEI: 3002995837 • Gimhae-si, Gyeongsanghnam-do • SOUTH KOREA
FEI Number
3002995837
Location
Gimhae-si, Gyeongsanghnam-do
Country
SOUTH KOREAAddress
768 Gomoro Hallim-myeon, , Gimhae-si, Gyeongsanghnam-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.
STD QUALIT
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(h)(1) of the FD&C Act in that the article purports to be or is represented as a food for which a standard of quality has been prescribed by regulation as provided by Section 401 of the FD&C Act, and its quality falls below such standard and its label does not bear a statement that it falls below such standard in such manner and form as such regulations specify.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/14/2009 | 13YFT99ICE CREAM AND RELATED PRODUCTS, N.E.C. | 254STD QUALIT | New York District Office (NYK-DO) |
| 11/17/2006 | 29ADT70SOFT DRINK, MILK BASED (CHOCOLATE FLAVORED, ETC.), NONCARBONATED | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 10/16/2006 | 29ADT70SOFT DRINK, MILK BASED (CHOCOLATE FLAVORED, ETC.), NONCARBONATED | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 10/16/2006 | 29ADT70SOFT DRINK, MILK BASED (CHOCOLATE FLAVORED, ETC.), NONCARBONATED | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Binggrae Co. Ltd.'s FDA import refusal history?
Binggrae Co. Ltd. (FEI: 3002995837) has 4 FDA import refusal record(s) in our database, spanning from 10/16/2006 to 9/14/2009.
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. Binggrae Co. Ltd.'s FEI number is 3002995837.
What types of violations has Binggrae Co. Ltd. received?
Binggrae Co. Ltd. has been cited for 2 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 Binggrae Co. Ltd. come from?
All FDA import refusal data for Binggrae 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.