Medopharm Pvt Ltd
⚠️ Moderate Risk
FEI: 3006304653 • Guduvencherry • INDIA
FEI Number
3006304653
Location
Guduvencherry
Country
INDIAAddress
50 Kayarambedu Village, , Guduvencherry, , 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
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).
COL ADDED
The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/29/2022 | 56BCK05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 2/28/2018 | 56BCF07AMPICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | Division of Northeast Imports (DNEI) | |
| 2/28/2018 | 62GBA99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Medopharm Pvt Ltd's FDA import refusal history?
Medopharm Pvt Ltd (FEI: 3006304653) has 3 FDA import refusal record(s) in our database, spanning from 2/28/2018 to 3/29/2022.
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 Pvt Ltd's FEI number is 3006304653.
What types of violations has Medopharm Pvt Ltd received?
Medopharm 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 Medopharm Pvt Ltd come from?
All FDA import refusal data for Medopharm 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.