LINHAI CITY CHENHONG GLASSES CO
⚠️ Moderate Risk
FEI: 3017086795 • Linhai City • CHINA
FEI Number
3017086795
Location
Linhai City
Country
CHINAAddress
No 38 Antou Dafen Duqia, , Linhai City, , 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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/3/2020 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/16/2020 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/16/2020 | 86HQZFRAME, SPECTACLE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 8/17/2020 | 86HQZFRAME, SPECTACLE | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is LINHAI CITY CHENHONG GLASSES CO's FDA import refusal history?
LINHAI CITY CHENHONG GLASSES CO (FEI: 3017086795) has 4 FDA import refusal record(s) in our database, spanning from 8/17/2020 to 12/3/2020.
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 CITY CHENHONG GLASSES CO's FEI number is 3017086795.
What types of violations has LINHAI CITY CHENHONG GLASSES CO received?
LINHAI CITY CHENHONG GLASSES CO 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 CITY CHENHONG GLASSES CO come from?
All FDA import refusal data for LINHAI CITY CHENHONG GLASSES CO 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.