Guangzhou Xianda Spectacles Factory
⚠️ Moderate Risk
FEI: 3003858178 • Guangzhou Guangton, Guangton • CHINA
FEI Number
3003858178
Location
Guangzhou Guangton, Guangton
Country
CHINAAddress
Xin Shi Town, Ping Sha Road,, New Guang Hua, Guangzhou Guangton, Guangton, 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.
NOT IMPACT
The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/12/2016 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Southeast Imports (DSEI) | |
| 10/26/2015 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Seattle District Office (SEA-DO) | |
| 4/29/2015 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Guangzhou Xianda Spectacles Factory's FDA import refusal history?
Guangzhou Xianda Spectacles Factory (FEI: 3003858178) has 3 FDA import refusal record(s) in our database, spanning from 4/29/2015 to 8/12/2016.
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. Guangzhou Xianda Spectacles Factory's FEI number is 3003858178.
What types of violations has Guangzhou Xianda Spectacles Factory received?
Guangzhou Xianda Spectacles Factory has been cited for 3 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 Guangzhou Xianda Spectacles Factory come from?
All FDA import refusal data for Guangzhou Xianda Spectacles Factory 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.