SHINWHA AQUA CO., LTD.
⚠️ Moderate Risk
FEI: 2000038778 • Gwangjin Gu, None of the above • SOUTH KOREA
FEI Number
2000038778
Location
Gwangjin Gu, None of the above
Country
SOUTH KOREAAddress
3f Ousin B/D, 130-7, Junggog 2 Dong, , Gwangjin Gu, None of the above, 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
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 |
|---|---|---|---|
| 1/7/2011 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 1/7/2011 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 1/7/2011 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New York District Office (NYK-DO) |
Frequently Asked Questions
What is SHINWHA AQUA CO., LTD.'s FDA import refusal history?
SHINWHA AQUA CO., LTD. (FEI: 2000038778) has 3 FDA import refusal record(s) in our database, spanning from 1/7/2011 to 1/7/2011.
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. SHINWHA AQUA CO., LTD.'s FEI number is 2000038778.
What types of violations has SHINWHA AQUA CO., LTD. received?
SHINWHA AQUA CO., LTD. has been cited for 1 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 SHINWHA AQUA CO., LTD. come from?
All FDA import refusal data for SHINWHA AQUA 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.