Glovco (M) Sdn Bhd
⚠️ Moderate Risk
FEI: 3001441743 • Darul Ehsan, Darul Ehsan • MALAYSIA
FEI Number
3001441743
Location
Darul Ehsan, Darul Ehsan
Country
MALAYSIAAddress
Lot 760, Jalan Haji Sirat, 42100 Klang, Selangor, Darul Ehsan, Darul Ehsan, 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 |
|---|---|---|---|
| 6/1/2007 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Minneapolis District Office (MIN-DO) |
| 5/7/2007 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Atlanta District Office (ATL-DO) |
| 4/11/2007 | 80FMCGLOVE, PATIENT EXAMINATION | 477HOLES | Atlanta District Office (ATL-DO) |
| 2/16/2007 | 80FMCGLOVE, PATIENT EXAMINATION | 477HOLES | Minneapolis District Office (MIN-DO) |
Frequently Asked Questions
What is Glovco (M) Sdn Bhd's FDA import refusal history?
Glovco (M) Sdn Bhd (FEI: 3001441743) has 4 FDA import refusal record(s) in our database, spanning from 2/16/2007 to 6/1/2007.
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. Glovco (M) Sdn Bhd's FEI number is 3001441743.
What types of violations has Glovco (M) Sdn Bhd received?
Glovco (M) 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 Glovco (M) Sdn Bhd come from?
All FDA import refusal data for Glovco (M) 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.