Handsafe Products Sdn. Bhd
⚠️ Moderate Risk
FEI: 1000604230 • Muar, Johor • MALAYSIA
FEI Number
1000604230
Location
Muar, Johor
Country
MALAYSIAAddress
Lot 6021, Kawasan Perindustrian, Bukit Bakri, Muar, Johor, 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
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
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
Frequently Asked Questions
What is Handsafe Products Sdn. Bhd's FDA import refusal history?
Handsafe Products Sdn. Bhd (FEI: 1000604230) has 1 FDA import refusal record(s) in our database, spanning from 1/19/2007 to 1/19/2007.
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. Handsafe Products Sdn. Bhd's FEI number is 1000604230.
What types of violations has Handsafe Products Sdn. Bhd received?
Handsafe Products Sdn. Bhd has been cited for 3 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 Handsafe Products Sdn. Bhd come from?
All FDA import refusal data for Handsafe Products 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.