ADVEN BIOTECH PVT LTD
✅ Low Risk
FEI: 3012893865 • HARYANA • INDIA
FEI Number
3012893865
Location
HARYANA
Country
INDIAAddress
PLOT NO. 70 SECTOR 5 IM, , HARYANA, , 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
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
Refusal History
Frequently Asked Questions
What is ADVEN BIOTECH PVT LTD's FDA import refusal history?
ADVEN BIOTECH PVT LTD (FEI: 3012893865) has 1 FDA import refusal record(s) in our database, spanning from 11/28/2016 to 11/28/2016.
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. ADVEN BIOTECH PVT LTD's FEI number is 3012893865.
What types of violations has ADVEN BIOTECH PVT LTD received?
ADVEN BIOTECH PVT 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 ADVEN BIOTECH PVT LTD come from?
All FDA import refusal data for ADVEN BIOTECH 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.