Pleasure Latex Products Sdn. Bhd
✅ Low Risk
FEI: 3004417860 • Jeram, Selangor • MALAYSIA
FEI Number
3004417860
Location
Jeram, Selangor
Country
MALAYSIAAddress
Lot 2401, 17th Jalan Middle, Jeram, Selangor, Malaysia
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
Frequently Asked Questions
What is Pleasure Latex Products Sdn. Bhd's FDA import refusal history?
Pleasure Latex Products Sdn. Bhd (FEI: 3004417860) has 2 FDA import refusal record(s) in our database, spanning from 5/7/2009 to 12/23/2010.
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. Pleasure Latex Products Sdn. Bhd's FEI number is 3004417860.
What types of violations has Pleasure Latex Products Sdn. Bhd received?
Pleasure Latex Products 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 Pleasure Latex Products Sdn. Bhd come from?
All FDA import refusal data for Pleasure Latex 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.