TOPTEC CO. LTD.
⚠️ Moderate Risk
FEI: 3016790437 • Asan-Si, CHUNGCHEONGNAMDO • SOUTH KOREA
FEI Number
3016790437
Location
Asan-Si, CHUNGCHEONGNAMDO
Country
SOUTH KOREAAddress
122 Asanvalley-Ro, Dunpo-Myeon, Asan-Si, CHUNGCHEONGNAMDO, 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
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/24/2022 | 80FXXMASK, SURGICAL | Division of West Coast Imports (DWCI) | |
| 3/22/2022 | 80FXXMASK, SURGICAL | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 3/22/2022 | 80FXXMASK, SURGICAL | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 3/22/2022 | 80LYUACCESSORY, SURGICAL APPAREL | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 9/15/2021 | 80FXXMASK, SURGICAL | Division of West Coast Imports (DWCI) | |
| 7/22/2020 | 80FXXMASK, SURGICAL | 479DV QUALITY | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is TOPTEC CO. LTD.'s FDA import refusal history?
TOPTEC CO. LTD. (FEI: 3016790437) has 6 FDA import refusal record(s) in our database, spanning from 7/22/2020 to 3/24/2022.
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 3016790437.
What types of violations has TOPTEC CO. LTD. received?
TOPTEC 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 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.