Sky International
⚠️ Moderate Risk
FEI: 3007294752 • Seoul • SOUTH KOREA
FEI Number
3007294752
Location
Seoul
Country
SOUTH KOREAAddress
Rm504 Chunglim Bldg #641-11, , 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/11/2014 | 89IMEPACK, HOT OR COLD, REUSEABLE | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 4/11/2014 | 76EFWTOOTHBRUSH, MANUAL | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 4/11/2014 | 63RBY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 118NOT LISTED | Atlanta District Office (ATL-DO) |
Frequently Asked Questions
What is Sky International's FDA import refusal history?
Sky International (FEI: 3007294752) has 3 FDA import refusal record(s) in our database, spanning from 4/11/2014 to 4/11/2014.
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. Sky International's FEI number is 3007294752.
What types of violations has Sky International received?
Sky International 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 Sky International come from?
All FDA import refusal data for Sky International 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.