Insung Natural Co., Ltd.
⚠️ Moderate Risk
FEI: 3004330002 • Kangnam, Seoul Teugbyeolsi • SOUTH KOREA
FEI Number
3004330002
Location
Kangnam, Seoul Teugbyeolsi
Country
SOUTH KOREAAddress
169-11 Samsungng, , Kangnam, Seoul Teugbyeolsi, 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
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
FALSE
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(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
SUBSTITUTE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears that a substance has been substituted wholly or in part for one or more of the article's ingredients.
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/25/2011 | 65RBA99REPLENISHER N.E.C. | Los Angeles District Office (LOS-DO) | |
| 4/25/2011 | 63HBF99CATHARTIC N.E.C. | Los Angeles District Office (LOS-DO) | |
| 4/25/2011 | 61JBF99ANTI-CHOLESTEREMIC, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 4/25/2011 | 62HBF99ANTI-MICROBIAL N.E.C. | Los Angeles District Office (LOS-DO) | |
| 4/25/2011 | 65RBA99REPLENISHER N.E.C. | Los Angeles District Office (LOS-DO) | |
| 4/25/2011 | 53JK01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | Los Angeles District Office (LOS-DO) | |
| 4/25/2011 | 53JK01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | Los Angeles District Office (LOS-DO) | |
| 4/25/2011 | 65CBK99NUTRIENT/TONIC N.E.C. | Los Angeles District Office (LOS-DO) | |
| 4/25/2011 | 65RBB99REPLENISHER N.E.C. | Los Angeles District Office (LOS-DO) | |
| 4/25/2011 | 63SBY99DENTAL PROTECTANT N.E.C. | Los Angeles District Office (LOS-DO) | |
| 9/1/2010 | 66VBH99MISCELLANEOUS PATENT MEDICINES, ETC. | 342PERSONALRX | Los Angeles District Office (LOS-DO) |
| 9/1/2010 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 9/1/2010 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Insung Natural Co., Ltd.'s FDA import refusal history?
Insung Natural Co., Ltd. (FEI: 3004330002) has 13 FDA import refusal record(s) in our database, spanning from 9/1/2010 to 4/25/2011.
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. Insung Natural Co., Ltd.'s FEI number is 3004330002.
What types of violations has Insung Natural Co., Ltd. received?
Insung Natural Co., Ltd. has been cited for 7 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 Insung Natural Co., Ltd. come from?
All FDA import refusal data for Insung Natural 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.