Perusahaan Getah Asas Sdn Bhd
⚠️ Moderate Risk
FEI: 3004553390 • Selangor • MALAYSIA
FEI Number
3004553390
Location
Selangor
Country
MALAYSIAAddress
Lot 1365, Batu 17, Jalan Sungai, Sembilang, Jeram, Selangor, , 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 |
|---|---|---|---|
| 5/31/2011 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Southwest Import District Office (SWI-DO) |
| 10/30/2009 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Atlanta District Office (ATL-DO) |
| 10/8/2009 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Atlanta District Office (ATL-DO) |
| 4/14/2009 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Perusahaan Getah Asas Sdn Bhd's FDA import refusal history?
Perusahaan Getah Asas Sdn Bhd (FEI: 3004553390) has 4 FDA import refusal record(s) in our database, spanning from 4/14/2009 to 5/31/2011.
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. Perusahaan Getah Asas Sdn Bhd's FEI number is 3004553390.
What types of violations has Perusahaan Getah Asas Sdn Bhd received?
Perusahaan Getah Asas Sdn Bhd 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 Perusahaan Getah Asas Sdn Bhd come from?
All FDA import refusal data for Perusahaan Getah Asas 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.