ADVANCE MEDICAL PRODUCTS
⚠️ Moderate Risk
FEI: 3009489003 • Ayer Tawar, Perak • MALAYSIA
FEI Number
3009489003
Location
Ayer Tawar, Perak
Country
MALAYSIAAddress
Lot 8961 & 8964, Batu 19, Ayer Tawar, Perak, Malaysia
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
HOLES
The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/16/2018 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of West Coast Imports (DWCI) |
| 8/15/2018 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of Northeast Imports (DNEI) |
| 8/15/2018 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of Northeast Imports (DNEI) |
| 7/26/2018 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of Northeast Imports (DNEI) |
| 7/26/2018 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of Northeast Imports (DNEI) |
| 7/6/2018 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of Northeast Imports (DNEI) |
| 5/18/2018 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of Southwest Imports (DSWI) |
| 10/1/2015 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Atlanta District Office (ATL-DO) |
| 10/1/2015 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Atlanta District Office (ATL-DO) |
| 10/1/2015 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Atlanta District Office (ATL-DO) |
Frequently Asked Questions
What is ADVANCE MEDICAL PRODUCTS's FDA import refusal history?
ADVANCE MEDICAL PRODUCTS (FEI: 3009489003) has 10 FDA import refusal record(s) in our database, spanning from 10/1/2015 to 8/16/2018.
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. ADVANCE MEDICAL PRODUCTS's FEI number is 3009489003.
What types of violations has ADVANCE MEDICAL PRODUCTS received?
ADVANCE MEDICAL PRODUCTS has been cited for 1 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 ADVANCE MEDICAL PRODUCTS come from?
All FDA import refusal data for ADVANCE MEDICAL PRODUCTS 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.