Able C & C Co., Ltd.
⚠️ Moderate Risk
FEI: 3004989717 • Seoul, Seoul • SOUTH KOREA
FEI Number
3004989717
Location
Seoul, Seoul
Country
SOUTH KOREAAddress
119 Gasan digital 1-ro, Geumcheon-Gu, Seoul, Seoul, 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
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).
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).
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.
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 |
|---|---|---|---|
| 7/21/2015 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/5/2014 | 65LBJ11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/5/2014 | 65LBJ11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/5/2014 | 65LBJ11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/5/2014 | 65LBJ11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/5/2014 | 65LBJ11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/5/2014 | 65LBJ11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/5/2014 | 65LBJ11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/5/2014 | 65LBJ11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/5/2014 | 65LBJ11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/5/2014 | 65LBJ11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/5/2014 | 65LBJ11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/5/2014 | 65LBJ11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/5/2014 | 65LBJ11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/5/2014 | 65LBJ11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/5/2014 | 65LBJ11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/5/2014 | 65LBJ11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/5/2014 | 65LBJ11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/5/2014 | 65LBJ11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/5/2014 | 65LBJ11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/5/2014 | 65LBJ11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/5/2014 | 65LBJ11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/5/2014 | 65LBJ11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/5/2014 | 65LBJ11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/5/2014 | 65LBJ11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/5/2014 | 65LBJ11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/5/2014 | 65LBJ11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/5/2014 | 65LBJ11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/5/2014 | 65LBJ11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/5/2014 | 65LBJ11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/5/2014 | 65LBJ11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/5/2014 | 65LBJ11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/5/2014 | 65LBJ11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 3/6/2014 | 65LBJ11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 8/9/2013 | 65LBJ11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 11/23/2012 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 7/31/2012 | 65LBJ11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 7/31/2012 | 65LBJ11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 7/26/2012 | 53LC10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | Seattle District Office (SEA-DO) | |
| 7/24/2012 | 65LBJ11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 7/24/2012 | 65LBJ11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 10/1/2009 | 66VDJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 10/1/2009 | 66VDJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 10/1/2009 | 66VDJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 10/1/2009 | 66VDJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 10/1/2009 | 66VDJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 10/1/2009 | 66VDJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Able C & C Co., Ltd.'s FDA import refusal history?
Able C & C Co., Ltd. (FEI: 3004989717) has 47 FDA import refusal record(s) in our database, spanning from 10/1/2009 to 7/21/2015.
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. Able C & C Co., Ltd.'s FEI number is 3004989717.
What types of violations has Able C & C Co., Ltd. received?
Able C & C Co., Ltd. has been cited for 4 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 Able C & C Co., Ltd. come from?
All FDA import refusal data for Able C & C 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.