MAKTREX INTERNATIONAL
⚠️ Moderate Risk
FEI: 3017138548 • Delhi, Delhi • INDIA
FEI Number
3017138548
Location
Delhi, Delhi
Country
INDIAAddress
Pole No 125, 25 - A / 79&80 Main Pandav Road, Delhi, Delhi, 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.
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/4/2024 | 89NGXSTIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING | Division of Southeast Imports (DSEI) | |
| 7/25/2024 | 89IPFSTIMULATOR, MUSCLE, POWERED | Division of Northeast Imports (DNEI) | |
| 4/19/2024 | 89IPFSTIMULATOR, MUSCLE, POWERED | Division of Southeast Imports (DSEI) | |
| 5/18/2023 | 89IMGSTIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT | Division of Southeast Imports (DSEI) | |
| 8/19/2020 | 89LXFDIATHERMY, ULTRASONIC, FOR USE OTHER THAN APPLYING THERAPEUTIC DEEP HEAT | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is MAKTREX INTERNATIONAL's FDA import refusal history?
MAKTREX INTERNATIONAL (FEI: 3017138548) has 5 FDA import refusal record(s) in our database, spanning from 8/19/2020 to 11/4/2024.
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. MAKTREX INTERNATIONAL's FEI number is 3017138548.
What types of violations has MAKTREX INTERNATIONAL received?
MAKTREX INTERNATIONAL 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 MAKTREX INTERNATIONAL come from?
All FDA import refusal data for MAKTREX INTERNATIONAL 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.