Bioinon Sdn Bhd
✅ Low Risk
FEI: 3013145808 • Shah Alam, Selangor • MALAYSIA
FEI Number
3013145808
Location
Shah Alam, Selangor
Country
MALAYSIAAddress
1 Jalan Sungai Jeluh 32/192, Kawasan Perindustrian Kemuning, Shah Alam, 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
DIETARYLBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.
FALSE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
Refusal History
Frequently Asked Questions
What is Bioinon Sdn Bhd's FDA import refusal history?
Bioinon Sdn Bhd (FEI: 3013145808) has 1 FDA import refusal record(s) in our database, spanning from 7/24/2018 to 7/24/2018.
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. Bioinon Sdn Bhd's FEI number is 3013145808.
What types of violations has Bioinon Sdn Bhd received?
Bioinon 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 Bioinon Sdn Bhd come from?
All FDA import refusal data for Bioinon 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.