MEDONO INDIA
⚠️ Moderate Risk
FEI: 3027373490 • Alipur • INDIA
FEI Number
3027373490
Location
Alipur
Country
INDIAAddress
Kh-894/New 115 Ground F, , Alipur, , 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
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).
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.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/3/2023 | 79HTDFORCEPS | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/3/2023 | 80NSCINJECTOR, PEN | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/3/2023 | 79LRYPUNCH, SURGICAL | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/3/2023 | 79GEYMOTOR, SURGICAL INSTRUMENT, AC-POWERED | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/3/2023 | 79HTDFORCEPS | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 7/20/2023 | 79DWGELECTROSURGICAL DEVICE | Division of Southeast Imports (DSEI) | |
| 7/20/2023 | 79PKYIMPLANT, DERMAL, FOR AESTHETIC USE IN THE HANDS | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is MEDONO INDIA's FDA import refusal history?
MEDONO INDIA (FEI: 3027373490) has 7 FDA import refusal record(s) in our database, spanning from 7/20/2023 to 10/3/2023.
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. MEDONO INDIA's FEI number is 3027373490.
What types of violations has MEDONO INDIA received?
MEDONO INDIA has been cited for 3 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 MEDONO INDIA come from?
All FDA import refusal data for MEDONO INDIA 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.