LUXOTTICA INDIA EYEWEAR PVT LTD
✅ Low Risk
FEI: 3012503905 • GURGAON • INDIA
FEI Number
3012503905
Location
GURGAON
Country
INDIAAddress
7TH FLOOR, DLF BUILDING, , GURGAON, , India
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).
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
Frequently Asked Questions
What is LUXOTTICA INDIA EYEWEAR PVT LTD's FDA import refusal history?
LUXOTTICA INDIA EYEWEAR PVT LTD (FEI: 3012503905) has 1 FDA import refusal record(s) in our database, spanning from 8/17/2016 to 8/17/2016.
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. LUXOTTICA INDIA EYEWEAR PVT LTD's FEI number is 3012503905.
What types of violations has LUXOTTICA INDIA EYEWEAR PVT LTD received?
LUXOTTICA INDIA EYEWEAR PVT LTD 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 LUXOTTICA INDIA EYEWEAR PVT LTD come from?
All FDA import refusal data for LUXOTTICA INDIA EYEWEAR PVT 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.