Worldgate Vision Beverage Sdn Bhd
⚠️ High Risk
FEI: 3011235150 • Kuala Muda, Kedah • MALAYSIA
FEI Number
3011235150
Location
Kuala Muda, Kedah
Country
MALAYSIAAddress
Kawasan Perusahaan Sungai Tukang, 95 Lorong Enggang 6, Kuala Muda, Kedah, Malaysia
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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
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.
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.
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/6/2016 | 31EGT06HERBAL COFFEE (BLEND OF HERBS, GRAINS, FRUITS AND NUTS) | Seattle District Office (SEA-DO) | |
| 9/6/2016 | 31EGT06HERBAL COFFEE (BLEND OF HERBS, GRAINS, FRUITS AND NUTS) | Seattle District Office (SEA-DO) | |
| 9/6/2016 | 31EGT06HERBAL COFFEE (BLEND OF HERBS, GRAINS, FRUITS AND NUTS) | Seattle District Office (SEA-DO) | |
| 9/6/2016 | 31EGT06HERBAL COFFEE (BLEND OF HERBS, GRAINS, FRUITS AND NUTS) | Seattle District Office (SEA-DO) | |
| 9/6/2016 | 31EGT06HERBAL COFFEE (BLEND OF HERBS, GRAINS, FRUITS AND NUTS) | Seattle District Office (SEA-DO) | |
| 8/22/2016 | 31EET06HERBAL COFFEE (BLEND OF HERBS, GRAINS, FRUITS AND NUTS) | Seattle District Office (SEA-DO) | |
| 8/22/2016 | 31EFT06HERBAL COFFEE (BLEND OF HERBS, GRAINS, FRUITS AND NUTS) | Seattle District Office (SEA-DO) | |
| 8/22/2016 | 31EFT06HERBAL COFFEE (BLEND OF HERBS, GRAINS, FRUITS AND NUTS) | Seattle District Office (SEA-DO) | |
| 8/22/2016 | 31EFT06HERBAL COFFEE (BLEND OF HERBS, GRAINS, FRUITS AND NUTS) | Seattle District Office (SEA-DO) | |
| 8/22/2016 | 31EFT06HERBAL COFFEE (BLEND OF HERBS, GRAINS, FRUITS AND NUTS) | Seattle District Office (SEA-DO) | |
| 8/22/2016 | 31EFT06HERBAL COFFEE (BLEND OF HERBS, GRAINS, FRUITS AND NUTS) | Seattle District Office (SEA-DO) | |
| 8/22/2016 | 31EFT06HERBAL COFFEE (BLEND OF HERBS, GRAINS, FRUITS AND NUTS) | Seattle District Office (SEA-DO) | |
| 8/22/2016 | 31EFT06HERBAL COFFEE (BLEND OF HERBS, GRAINS, FRUITS AND NUTS) | Seattle District Office (SEA-DO) | |
| 8/22/2016 | 31EFT06HERBAL COFFEE (BLEND OF HERBS, GRAINS, FRUITS AND NUTS) | Seattle District Office (SEA-DO) | |
| 8/22/2016 | 31EFT06HERBAL COFFEE (BLEND OF HERBS, GRAINS, FRUITS AND NUTS) | Seattle District Office (SEA-DO) | |
| 8/22/2016 | 31EFT06HERBAL COFFEE (BLEND OF HERBS, GRAINS, FRUITS AND NUTS) | Seattle District Office (SEA-DO) | |
| 8/22/2016 | 31EFT06HERBAL COFFEE (BLEND OF HERBS, GRAINS, FRUITS AND NUTS) | Seattle District Office (SEA-DO) | |
| 8/22/2016 | 31EET06HERBAL COFFEE (BLEND OF HERBS, GRAINS, FRUITS AND NUTS) | Seattle District Office (SEA-DO) | |
| 8/22/2016 | 31EET06HERBAL COFFEE (BLEND OF HERBS, GRAINS, FRUITS AND NUTS) | Seattle District Office (SEA-DO) | |
| 8/22/2016 | 31EET06HERBAL COFFEE (BLEND OF HERBS, GRAINS, FRUITS AND NUTS) | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Worldgate Vision Beverage Sdn Bhd's FDA import refusal history?
Worldgate Vision Beverage Sdn Bhd (FEI: 3011235150) has 20 FDA import refusal record(s) in our database, spanning from 8/22/2016 to 9/6/2016.
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. Worldgate Vision Beverage Sdn Bhd's FEI number is 3011235150.
What types of violations has Worldgate Vision Beverage Sdn Bhd received?
Worldgate Vision Beverage Sdn Bhd has been cited for 5 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 Worldgate Vision Beverage Sdn Bhd come from?
All FDA import refusal data for Worldgate Vision Beverage 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.