Xie Gang Kong Chung Hing Optical Manufactory
⚠️ Moderate Risk
FEI: 3002623833 • Dongguan • CHINA
FEI Number
3002623833
Location
Dongguan
Country
CHINAAddress
Kong Chung Hing Bldg., Xie Gang Town, Dongguan, , 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
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).
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.
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 |
|---|---|---|---|
| 3/13/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 6/23/2014 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | New Orleans District Office (NOL-DO) | |
| 8/13/2009 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 341REGISTERED | San Francisco District Office (SAN-DO) |
| 7/7/2009 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Xie Gang Kong Chung Hing Optical Manufactory's FDA import refusal history?
Xie Gang Kong Chung Hing Optical Manufactory (FEI: 3002623833) has 4 FDA import refusal record(s) in our database, spanning from 7/7/2009 to 3/13/2018.
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. Xie Gang Kong Chung Hing Optical Manufactory's FEI number is 3002623833.
What types of violations has Xie Gang Kong Chung Hing Optical Manufactory received?
Xie Gang Kong Chung Hing Optical Manufactory has been cited for 4 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 Xie Gang Kong Chung Hing Optical Manufactory come from?
All FDA import refusal data for Xie Gang Kong Chung Hing Optical Manufactory 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.