VENNER MEDICAL (SINGAPORE) PTE LTD
✅ Low Risk
FEI: 3007740622 • Singapore • SINGAPORE
FEI Number
3007740622
Location
Singapore
Country
SINGAPOREAddress
35 Joo Koon Circle, , Singapore, , Singapore
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
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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 VENNER MEDICAL (SINGAPORE) PTE LTD's FDA import refusal history?
VENNER MEDICAL (SINGAPORE) PTE LTD (FEI: 3007740622) has 1 FDA import refusal record(s) in our database, spanning from 5/29/2018 to 5/29/2018.
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. VENNER MEDICAL (SINGAPORE) PTE LTD's FEI number is 3007740622.
What types of violations has VENNER MEDICAL (SINGAPORE) PTE LTD received?
VENNER MEDICAL (SINGAPORE) PTE LTD 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 VENNER MEDICAL (SINGAPORE) PTE LTD come from?
All FDA import refusal data for VENNER MEDICAL (SINGAPORE) PTE LTD 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.