SANSKAR AYSUSH MEDICARE PVC LTD
⚠️ High Risk
FEI: 3031116414 • Uttarakhand • INDIA
FEI Number
3031116414
Location
Uttarakhand
Country
INDIAAddress
Bhagwanpur - Haridwar R, , Uttarakhand, , India
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/14/2024 | 60CCY09PHENYLEPHRINE HCL (ADRENERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is SANSKAR AYSUSH MEDICARE PVC LTD's FDA import refusal history?
SANSKAR AYSUSH MEDICARE PVC LTD (FEI: 3031116414) has 1 FDA import refusal record(s) in our database, spanning from 6/14/2024 to 6/14/2024.
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. SANSKAR AYSUSH MEDICARE PVC LTD's FEI number is 3031116414.
What types of violations has SANSKAR AYSUSH MEDICARE PVC LTD received?
SANSKAR AYSUSH MEDICARE PVC LTD 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 SANSKAR AYSUSH MEDICARE PVC LTD come from?
All FDA import refusal data for SANSKAR AYSUSH MEDICARE PVC 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.