Asia Pacific Latex Sdn Bhd
⚠️ Moderate Risk
FEI: 3003362310 • Ipoh Perak • MALAYSIA
FEI Number
3003362310
Location
Ipoh Perak
Country
MALAYSIAAddress
Lot 12, Medan Tasek, Ipoh 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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/28/2005 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Los Angeles District Office (LOS-DO) |
| 3/1/2005 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | New York District Office (NYK-DO) |
| 9/27/2004 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | New York District Office (NYK-DO) |
| 7/15/2004 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | New York District Office (NYK-DO) |
| 7/15/2004 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | New York District Office (NYK-DO) |
| 5/17/2004 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 118NOT LISTED | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Asia Pacific Latex Sdn Bhd's FDA import refusal history?
Asia Pacific Latex Sdn Bhd (FEI: 3003362310) has 6 FDA import refusal record(s) in our database, spanning from 5/17/2004 to 6/28/2005.
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. Asia Pacific Latex Sdn Bhd's FEI number is 3003362310.
What types of violations has Asia Pacific Latex Sdn Bhd received?
Asia Pacific Latex Sdn Bhd has been cited for 2 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 Asia Pacific Latex Sdn Bhd come from?
All FDA import refusal data for Asia Pacific Latex Sdn Bhd 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.