Lotte Samkang Co., Ltd.
⚠️ Moderate Risk
FEI: 3004257006 • Youngdeungpo, None of the above • SOUTH KOREA
FEI Number
3004257006
Location
Youngdeungpo, None of the above
Country
SOUTH KOREAAddress
6ga, Munraeng, , Youngdeungpo, None of the above, 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
MELAMINE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to bear or contain a food additive, namely melamine and/or a melamine analog, that is unsafe within the meaning of section 409.
STD IDENT
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(g)(1) of the FD&C Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard.
UNFIT4FOOD
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be unfit for food.
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.
NEEDS FCE
It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).
UNSAFE ADD
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.
POISONOUS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. Contains:
WRONG IDEN
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 as defined in section 403(b) of the FD&C Act. The article appears to be offered for sale under the name of another food.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/16/2022 | 13EGD01ICE CREAM BARS | 3421MELAMINE | Division of West Coast Imports (DWCI) |
| 1/14/2013 | 13EGT99ICE CREAM BARS AND OTHER NOVELTY ITEMS, N.E.C. | 3421MELAMINE | Southwest Import District Office (SWI-DO) |
| 4/23/2012 | 13EGT99ICE CREAM BARS AND OTHER NOVELTY ITEMS, N.E.C. | 3421MELAMINE | San Francisco District Office (SAN-DO) |
| 4/23/2012 | 13EGT99ICE CREAM BARS AND OTHER NOVELTY ITEMS, N.E.C. | 3421MELAMINE | San Francisco District Office (SAN-DO) |
| 1/18/2011 | 13YGT99ICE CREAM AND RELATED PRODUCTS, N.E.C. | 3421MELAMINE | San Francisco District Office (SAN-DO) |
| 8/27/2010 | 13EGT01ICE CREAM BARS | 3421MELAMINE | Los Angeles District Office (LOS-DO) |
| 8/27/2010 | 13EGD02ICE CREAM AND RELATED PRODUCTS ON A STICK(S) (EXCLUDING FRUIT FLAVORED ICES) | Chicago District Office (CHI-DO) | |
| 2/19/2010 | 13YGT99ICE CREAM AND RELATED PRODUCTS, N.E.C. | 253STD IDENT | San Francisco District Office (SAN-DO) |
| 3/16/2009 | 13EGD01ICE CREAM BARS | 3421MELAMINE | Los Angeles District Office (LOS-DO) |
| 1/15/2009 | 13EGO01ICE CREAM BARS | 3421MELAMINE | Baltimore District Office (BLT-DO) |
| 12/11/2008 | 13EGT99ICE CREAM BARS AND OTHER NOVELTY ITEMS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 12/19/2005 | 03RGD01CAKE WITHOUT CUSTARD OR CREAM FILLING | San Francisco District Office (SAN-DO) | |
| 11/5/2004 | 37JHY99SAUCES, N.E.C. | 62NEEDS FCE | Chicago District Office (CHI-DO) |
| 4/9/2002 | 13EGD01ICE CREAM BARS | 218LIST INGRE | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Lotte Samkang Co., Ltd.'s FDA import refusal history?
Lotte Samkang Co., Ltd. (FEI: 3004257006) has 14 FDA import refusal record(s) in our database, spanning from 4/9/2002 to 5/16/2022.
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. Lotte Samkang Co., Ltd.'s FEI number is 3004257006.
What types of violations has Lotte Samkang Co., Ltd. received?
Lotte Samkang Co., Ltd. has been cited for 8 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 Lotte Samkang Co., Ltd. come from?
All FDA import refusal data for Lotte Samkang 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.