Cotde Inc.
⚠️ Moderate Risk
FEI: 3008748590 • Chungcheongnamdo • SOUTH KOREA
FEI Number
3008748590
Location
Chungcheongnamdo
Country
SOUTH KOREAAddress
Production Bd #2303 Chungnam Techno Park, , Chungcheongnamdo, , 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
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 |
|---|---|---|---|
| 5/13/2011 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | Los Angeles District Office (LOS-DO) |
| 5/13/2011 | 62WBY07WHITE LOTION ASTRINGENT/ANTI-PERSPIRANT) | 16DIRECTIONS | Los Angeles District Office (LOS-DO) |
| 5/13/2011 | 62WBY07WHITE LOTION ASTRINGENT/ANTI-PERSPIRANT) | 16DIRECTIONS | Los Angeles District Office (LOS-DO) |
| 5/13/2011 | 62WBY07WHITE LOTION ASTRINGENT/ANTI-PERSPIRANT) | 16DIRECTIONS | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Cotde Inc.'s FDA import refusal history?
Cotde Inc. (FEI: 3008748590) has 4 FDA import refusal record(s) in our database, spanning from 5/13/2011 to 5/13/2011.
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. Cotde Inc.'s FEI number is 3008748590.
What types of violations has Cotde Inc. received?
Cotde Inc. has been cited for 2 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 Cotde Inc. come from?
All FDA import refusal data for Cotde Inc. 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.