TOPTEC CO LTD
⚠️ Moderate Risk
FEI: 3020404801 • Gumi • SOUTH KOREA
FEI Number
3020404801
Location
Gumi
Country
SOUTH KOREAAddress
140-22 Cheomdangieop 5-, , Gumi, , 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
DV QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/31/2022 | 80FXXMASK, SURGICAL | Division of Northern Border Imports (DNBI) | |
| 2/25/2022 | 80FXXMASK, SURGICAL | 237NO PMA | Division of Southeast Imports (DSEI) |
| 2/22/2022 | 80FXXMASK, SURGICAL | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 11/8/2021 | 80FXXMASK, SURGICAL | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is TOPTEC CO LTD's FDA import refusal history?
TOPTEC CO LTD (FEI: 3020404801) has 4 FDA import refusal record(s) in our database, spanning from 11/8/2021 to 3/31/2022.
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. TOPTEC CO LTD's FEI number is 3020404801.
What types of violations has TOPTEC CO LTD received?
TOPTEC CO LTD has been cited for 3 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 TOPTEC CO LTD come from?
All FDA import refusal data for TOPTEC 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.