GMP Medicare Sdn Bhd(F25)
⚠️ High Risk
FEI: 3006796582 • Klang, Selangor • MALAYSIA
FEI Number
3006796582
Location
Klang, Selangor
Country
MALAYSIAAddress
Lot/PT 64593, Jalan Dahlia/KU8, Kawasan Perindustrian Meru Timur, Klang, Selangor, Malaysia
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
HOLES
The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
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 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.
3904
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/29/2025 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of West Coast Imports (DWCI) | |
| 10/29/2025 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of West Coast Imports (DWCI) | |
| 10/29/2025 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of West Coast Imports (DWCI) | |
| 10/3/2022 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of Northeast Imports (DNEI) |
| 10/3/2022 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of Northeast Imports (DNEI) |
| 6/23/2022 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of Southeast Imports (DSEI) |
| 6/23/2022 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of Southeast Imports (DSEI) |
| 6/23/2022 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of Southeast Imports (DSEI) |
| 6/23/2022 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of Southeast Imports (DSEI) |
| 6/23/2022 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of Southeast Imports (DSEI) |
| 11/16/2011 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | New York District Office (NYK-DO) |
Frequently Asked Questions
What is GMP Medicare Sdn Bhd(F25)'s FDA import refusal history?
GMP Medicare Sdn Bhd(F25) (FEI: 3006796582) has 11 FDA import refusal record(s) in our database, spanning from 11/16/2011 to 10/29/2025.
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. GMP Medicare Sdn Bhd(F25)'s FEI number is 3006796582.
What types of violations has GMP Medicare Sdn Bhd(F25) received?
GMP Medicare Sdn Bhd(F25) 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 GMP Medicare Sdn Bhd(F25) come from?
All FDA import refusal data for GMP Medicare Sdn Bhd(F25) 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.