ARTEMA MEDICAL GRO
⚠️ High Risk
FEI: 3038701333 • Lahore • PAKISTAN
FEI Number
3038701333
Location
Lahore
Country
PAKISTANAddress
371 J-Commercial B, , Lahore, , Pakistan
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
DE IMP GMP
The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities or controls used for, the manufacture of the device do not conform to the applicable requirements of section 520(f).
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).
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).
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.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
DEVGMPS
The article appears to be a device for which the methods, facilities, or controls used in, or the facilities or controls used for, its manufacture, packing, storage or installation do not conform to the requirements of Sec. 520(f) and any applicable variance under Sec. 520(f)(2).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/14/2025 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | Division of Southeast Imports (DSEI) | |
| 8/1/2025 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 8/1/2025 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 8/1/2025 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is ARTEMA MEDICAL GRO's FDA import refusal history?
ARTEMA MEDICAL GRO (FEI: 3038701333) has 4 FDA import refusal record(s) in our database, spanning from 8/1/2025 to 8/14/2025.
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. ARTEMA MEDICAL GRO's FEI number is 3038701333.
What types of violations has ARTEMA MEDICAL GRO received?
ARTEMA MEDICAL GRO has been cited for 6 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 ARTEMA MEDICAL GRO come from?
All FDA import refusal data for ARTEMA MEDICAL GRO 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.