Purnabina SDN BHD
⚠️ Moderate Risk
FEI: 1000253736 • Kluang, Johor • MALAYSIA
FEI Number
1000253736
Location
Kluang, Johor
Country
MALAYSIAAddress
Plot 5, Jalan Mahsuri 1, 7.5 Km, J., Jalan Mersing; Johor D. Takzim, Kluang, 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
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 Purnabina SDN BHD's FDA import refusal history?
Purnabina SDN BHD (FEI: 1000253736) has 2 FDA import refusal record(s) in our database, spanning from 12/16/2019 to 12/16/2019.
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. Purnabina SDN BHD's FEI number is 1000253736.
What types of violations has Purnabina SDN BHD received?
Purnabina 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 Purnabina SDN BHD come from?
All FDA import refusal data for Purnabina 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.