Silite Co., Ltd.
⚠️ Moderate Risk
FEI: 3009299275 • Goyangsi Kyungkido • SOUTH KOREA
FEI Number
3009299275
Location
Goyangsi Kyungkido
Country
SOUTH KOREAAddress
Hyundae Townvilie #612 848-1, Janghang, , Goyangsi Kyungkido, , 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
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
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).
Refusal History
Frequently Asked Questions
What is Silite Co., Ltd.'s FDA import refusal history?
Silite Co., Ltd. (FEI: 3009299275) has 1 FDA import refusal record(s) in our database, spanning from 10/29/2014 to 10/29/2014.
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. Silite Co., Ltd.'s FEI number is 3009299275.
What types of violations has Silite Co., Ltd. received?
Silite Co., Ltd. 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 Silite Co., Ltd. come from?
All FDA import refusal data for Silite 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.