Micron Eyewear Manufactory Co Ltd
✅ Low Risk
FEI: 3010180238 • Kowloon, Hong Kong • HONG KONG
FEI Number
3010180238
Location
Kowloon, Hong Kong
Country
HONG KONGAddress
A2, 10/F., Summit Bldg, 30 Man Yue St., Hung Hom, Kowloon, Kowloon, Hong Kong, Hong Kong
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
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.
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.
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
Frequently Asked Questions
What is Micron Eyewear Manufactory Co Ltd's FDA import refusal history?
Micron Eyewear Manufactory Co Ltd (FEI: 3010180238) has 1 FDA import refusal record(s) in our database, spanning from 12/6/2017 to 12/6/2017.
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. Micron Eyewear Manufactory Co Ltd's FEI number is 3010180238.
What types of violations has Micron Eyewear Manufactory Co Ltd received?
Micron Eyewear Manufactory Co Ltd 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 Micron Eyewear Manufactory Co Ltd come from?
All FDA import refusal data for Micron Eyewear Manufactory 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.