APR CORP, LTD
⚠️ Moderate Risk
FEI: 3016769192 • Songpa, Seoul Teugbyeolsi • SOUTH KOREA
FEI Number
3016769192
Location
Songpa, Seoul Teugbyeolsi
Country
SOUTH KOREAAddress
36f 300 Olympic-Ro, , Songpa, Seoul Teugbyeolsi, 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
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
Frequently Asked Questions
What is APR CORP, LTD's FDA import refusal history?
APR CORP, LTD (FEI: 3016769192) has 1 FDA import refusal record(s) in our database, spanning from 12/2/2024 to 12/2/2024.
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. APR CORP, LTD's FEI number is 3016769192.
What types of violations has APR CORP, LTD received?
APR CORP, 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 APR CORP, LTD come from?
All FDA import refusal data for APR CORP, 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.