Inel Cosmetics Co., Ltd.

⚠️ Moderate Risk

FEI: 3010165609 • Seoul, Seoul • SOUTH KOREA

FEI

FEI Number

3010165609

📍

Location

Seoul, Seoul

🇰🇷

Country

SOUTH KOREA

🏢

Address

463 Baekjegobun-ro, Songpagu, Seoul, Seoul, South Korea

Moderate Risk

FDA Import Risk Assessment

47.3

LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

Total Refusals

Unique Violations

6/19/2015

Latest Refusal

3/16/2007

Earliest Refusal

Score Breakdown

Violation Severity

57.3×40%

Refusal Volume

62.3×30%

Recency

0.0×20%

Frequency

56.9×10%

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

Violation Summary

11845×

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).

7511×

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).

328010×

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.

3303×

UNSAFE COL

The article appears to be a color additive for the purposes of coloring only in or on drugs or devices, and is unsafe within the meaning of Section 721(a).

4733×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

163×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

2231×

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.

4711×

CSTIC LBLG

The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.

Refusal History

Date	Product	Violations	Division
6/19/2015	65L99PROTECTANT N.E.C.	118NOT LISTED 3280FRNMFGREG	Division of Northeast Imports (DNEI)
6/19/2015	65L99PROTECTANT N.E.C.	118NOT LISTED 3280FRNMFGREG	Division of Northeast Imports (DNEI)
6/19/2015	65L99PROTECTANT N.E.C.	118NOT LISTED 3280FRNMFGREG	Division of Northeast Imports (DNEI)
6/19/2015	65L99PROTECTANT N.E.C.	118NOT LISTED 3280FRNMFGREG	Division of Northeast Imports (DNEI)
6/19/2015	65L99PROTECTANT N.E.C.	118NOT LISTED 3280FRNMFGREG	Division of Northeast Imports (DNEI)
6/19/2015	65L99PROTECTANT N.E.C.	118NOT LISTED 3280FRNMFGREG	Division of Northeast Imports (DNEI)
10/10/2011	53GD99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C.	118NOT LISTED 3280FRNMFGREG	Los Angeles District Office (LOS-DO)
10/10/2011	53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG	Los Angeles District Office (LOS-DO)
10/10/2011	53LD99OTHER SKIN CARE PREPARATIONS, N.E.C.	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG	Los Angeles District Office (LOS-DO)
10/10/2011	53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.	118NOT LISTED 16DIRECTIONS 223FALSE 3280FRNMFGREG	Los Angeles District Office (LOS-DO)
7/18/2011	66PBR99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.	118NOT LISTED 473LABELING	Philadelphia District Office (PHI-DO)
7/18/2011	66PBR99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.	118NOT LISTED 473LABELING	Philadelphia District Office (PHI-DO)
7/18/2011	66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 330UNSAFE COL 75UNAPPROVED	Philadelphia District Office (PHI-DO)
7/18/2011	66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.	118NOT LISTED 330UNSAFE COL	Philadelphia District Office (PHI-DO)
7/18/2011	66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.	118NOT LISTED 330UNSAFE COL	Philadelphia District Office (PHI-DO)
7/18/2011	66VBL99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	Philadelphia District Office (PHI-DO)
7/18/2011	66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	Philadelphia District Office (PHI-DO)
7/18/2011	66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	Philadelphia District Office (PHI-DO)
7/18/2011	66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.	118NOT LISTED 75UNAPPROVED	Philadelphia District Office (PHI-DO)
7/18/2011	66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.	118NOT LISTED 75UNAPPROVED	Philadelphia District Office (PHI-DO)
7/18/2011	66VBL99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	Philadelphia District Office (PHI-DO)
7/18/2011	66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	Philadelphia District Office (PHI-DO)
7/18/2011	66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	Philadelphia District Office (PHI-DO)
7/18/2011	66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.	118NOT LISTED	Philadelphia District Office (PHI-DO)
7/18/2011	66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.	118NOT LISTED	Philadelphia District Office (PHI-DO)
6/28/2011	66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.	75UNAPPROVED	Los Angeles District Office (LOS-DO)
6/28/2011	66PBU99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.	75UNAPPROVED	Los Angeles District Office (LOS-DO)
10/28/2010	66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.	118NOT LISTED	Los Angeles District Office (LOS-DO)
10/28/2010	66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.	118NOT LISTED	Los Angeles District Office (LOS-DO)
10/28/2010	66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.	118NOT LISTED	Los Angeles District Office (LOS-DO)
10/28/2010	66PBR99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.	118NOT LISTED	Los Angeles District Office (LOS-DO)
10/27/2010	66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.	118NOT LISTED 473LABELING	Los Angeles District Office (LOS-DO)
10/27/2010	66PBR99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.	118NOT LISTED	Los Angeles District Office (LOS-DO)
10/27/2010	66PBR99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.	118NOT LISTED	Los Angeles District Office (LOS-DO)
10/27/2010	66PBB99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.	118NOT LISTED	Los Angeles District Office (LOS-DO)
10/27/2010	66PBR99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.	118NOT LISTED	Los Angeles District Office (LOS-DO)
10/27/2010	66PBR99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.	118NOT LISTED	Los Angeles District Office (LOS-DO)
10/27/2010	66PBR99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.	118NOT LISTED	Los Angeles District Office (LOS-DO)
10/27/2010	66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.	118NOT LISTED	Los Angeles District Office (LOS-DO)
10/27/2010	66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.	118NOT LISTED	Los Angeles District Office (LOS-DO)
10/27/2010	66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.	118NOT LISTED	Los Angeles District Office (LOS-DO)
10/27/2010	66PBR99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.	118NOT LISTED	Los Angeles District Office (LOS-DO)
10/27/2010	66PBR99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.	118NOT LISTED	Los Angeles District Office (LOS-DO)
10/27/2010	66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.	118NOT LISTED	Los Angeles District Office (LOS-DO)
10/27/2010	66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.	118NOT LISTED	Los Angeles District Office (LOS-DO)
7/11/2008	53MD99OTHER SUNTAN PREPARATIONS (NOT SUNSCREEN), N.E.C.	118NOT LISTED 471CSTIC LBLG	Los Angeles District Office (LOS-DO)
3/16/2007	66PAJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.	118NOT LISTED	New York District Office (NYK-DO)

Frequently Asked Questions

What is Inel Cosmetics Co., Ltd.'s FDA import refusal history?

Inel Cosmetics Co., Ltd. (FEI: 3010165609) has 47 FDA import refusal record(s) in our database, spanning from 3/16/2007 to 6/19/2015.

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. Inel Cosmetics Co., Ltd.'s FEI number is 3010165609.

What types of violations has Inel Cosmetics Co., Ltd. received?

Inel Cosmetics 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 Inel Cosmetics Co., Ltd. come from?

All FDA import refusal data for Inel Cosmetics 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.