Medopharm
⚠️ High Risk
FEI: 3003965032 • Malur • 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).
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).
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
RX LEGEND
The article appears to be a prescription drug without a prescription drug legend as required by Section 503(b)(4).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/16/2025 | 62KCA08LOPERAMIDE HYDROCHLORIDE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 82RX LEGEND | Division of Southeast Imports (DSEI) |
| 7/16/2025 | 61XCA14CYPROHEPTADINE HCL (ANTI-HISTAMINIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/11/2005 | 61XAA08CHLORPHENIRAMINE MALEATE (ANTI-HISTAMINIC) | Southwest Import District Office (SWI-DO) | |
| 2/11/2005 | 61HDA03TRIMETHOPRIM (ANTI-BACTERIAL) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 2/11/2005 | 60TDA05CIMETIDINE (ANTAGONIST) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Medopharm's FDA import refusal history?
Medopharm (FEI: 3003965032) has 5 FDA import refusal record(s) in our database, spanning from 2/11/2005 to 7/16/2025.
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. Medopharm's FEI number is 3003965032.
What types of violations has Medopharm received?
Medopharm 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 Medopharm come from?
All FDA import refusal data for Medopharm 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.