LINHAI COOLGLASS TRADING CO LIMITED
⚠️ Moderate Risk
FEI: 3029968417 • Taizhou, Zhejiang • CHINA
FEI Number
3029968417
Location
Taizhou, Zhejiang
Country
CHINAAddress
3f West Side, #298 Tielutou, Zhuangliyang Village, Duqiao Town, Linhai, , Taizhou, Zhejiang, China
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).
LENS CERT
The lenses are declared by accompanying certificate to meet the requirements for impact-resistant lenses in 21 CFR 801.410 but does not appear to be impact-resistant.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/25/2024 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | Division of West Coast Imports (DWCI) | |
| 11/25/2024 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | Division of West Coast Imports (DWCI) | |
| 11/25/2024 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | Division of West Coast Imports (DWCI) | |
| 11/25/2024 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is LINHAI COOLGLASS TRADING CO LIMITED's FDA import refusal history?
LINHAI COOLGLASS TRADING CO LIMITED (FEI: 3029968417) has 4 FDA import refusal record(s) in our database, spanning from 11/25/2024 to 11/25/2024.
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. LINHAI COOLGLASS TRADING CO LIMITED's FEI number is 3029968417.
What types of violations has LINHAI COOLGLASS TRADING CO LIMITED received?
LINHAI COOLGLASS TRADING CO LIMITED 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 LINHAI COOLGLASS TRADING CO LIMITED come from?
All FDA import refusal data for LINHAI COOLGLASS TRADING CO LIMITED 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.