TDC, Co., Ltd.
⚠️ Moderate Risk
FEI: 3008256598 • Seoul, Seoul • SOUTH KOREA
FEI Number
3008256598
Location
Seoul, Seoul
Country
SOUTH KOREAAddress
91 Baekjegobun-ro, Songpa-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
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.
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).
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 |
|---|---|---|---|
| 10/11/2011 | 53LG08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | Los Angeles District Office (LOS-DO) | |
| 10/11/2011 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | Los Angeles District Office (LOS-DO) | |
| 10/11/2011 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | Los Angeles District Office (LOS-DO) | |
| 10/11/2011 | 53LC07NIGHT (SKIN CARE PREPARATIONS) | Los Angeles District Office (LOS-DO) | |
| 10/11/2011 | 53LC07NIGHT (SKIN CARE PREPARATIONS) | Los Angeles District Office (LOS-DO) | |
| 10/11/2011 | 53CC04EYE LOTION (EYE MAKEUP PREPARATIONS) | Los Angeles District Office (LOS-DO) | |
| 8/24/2010 | 53LC07NIGHT (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Los Angeles District Office (LOS-DO) |
| 8/24/2010 | 53LC07NIGHT (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is TDC, Co., Ltd.'s FDA import refusal history?
TDC, Co., Ltd. (FEI: 3008256598) has 8 FDA import refusal record(s) in our database, spanning from 8/24/2010 to 10/11/2011.
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. TDC, Co., Ltd.'s FEI number is 3008256598.
What types of violations has TDC, Co., Ltd. received?
TDC, Co., Ltd. has been cited for 3 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 TDC, Co., Ltd. come from?
All FDA import refusal data for TDC, 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.