Medilux Laboratories Private Limited
⚠️ Moderate Risk
FEI: 3005594847 • Dist. Dhar, Madhya Pradesh • INDIA
FEI Number
3005594847
Location
Dist. Dhar, Madhya Pradesh
Country
INDIAAddress
Plot No 98-99, Sector 1, Industrial Area, , Pithampur, Dist. Dhar, Madhya Pradesh, India
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
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 Medilux Laboratories Private Limited's FDA import refusal history?
Medilux Laboratories Private Limited (FEI: 3005594847) has 3 FDA import refusal record(s) in our database, spanning from 10/7/2024 to 10/24/2024.
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. Medilux Laboratories Private Limited's FEI number is 3005594847.
What types of violations has Medilux Laboratories Private Limited received?
Medilux Laboratories Private Limited has been cited for 1 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 Medilux Laboratories Private Limited come from?
All FDA import refusal data for Medilux Laboratories Private Limited 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.