FOREMOUNT ENTERPRISE CO LTD
✅ Low Risk
FEI: 3012538752 • TAICHUNG • TAIWAN
FEI Number
3012538752
Location
TAICHUNG
Country
TAIWANAddress
NO 17 ALLEY 15 LANE 5 S, , TAICHUNG, , Taiwan
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/10/2017 | 73BSJMASK, GAS, ANESTHETIC | 341REGISTERED | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is FOREMOUNT ENTERPRISE CO LTD's FDA import refusal history?
FOREMOUNT ENTERPRISE CO LTD (FEI: 3012538752) has 1 FDA import refusal record(s) in our database, spanning from 4/10/2017 to 4/10/2017.
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. FOREMOUNT ENTERPRISE CO LTD's FEI number is 3012538752.
What types of violations has FOREMOUNT ENTERPRISE CO LTD received?
FOREMOUNT ENTERPRISE CO LTD 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 FOREMOUNT ENTERPRISE CO LTD come from?
All FDA import refusal data for FOREMOUNT ENTERPRISE 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.