Vinh Tien
⚠️ Moderate Risk
FEI: 2000047527 • Dalat City, VN-35 • VIETNAM
FEI Number
2000047527
Location
Dalat City, VN-35
Country
VIETNAMAddress
162-164 Pham Ngoc Thach street, , Dalat City, VN-35, Vietnam
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
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).
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.
NEEDS FCE
It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/1/2008 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 11/1/2008 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 11/1/2008 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 11/1/2008 | 30BHE06BEVERAGE BASE, SUBTROPICAL OR TROPICAL FRUIT, LIQUID | 62NEEDS FCE | Los Angeles District Office (LOS-DO) |
| 11/1/2008 | 30BHE06BEVERAGE BASE, SUBTROPICAL OR TROPICAL FRUIT, LIQUID | 62NEEDS FCE | Los Angeles District Office (LOS-DO) |
| 4/15/2003 | 66VBR99MISCELLANEOUS PATENT MEDICINES, ETC. | 223FALSE | Los Angeles District Office (LOS-DO) |
| 4/15/2003 | 65VBY99SEDATIVE N.E.C. | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Vinh Tien's FDA import refusal history?
Vinh Tien (FEI: 2000047527) has 7 FDA import refusal record(s) in our database, spanning from 4/15/2003 to 11/1/2008.
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. Vinh Tien's FEI number is 2000047527.
What types of violations has Vinh Tien received?
Vinh Tien has been cited for 4 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 Vinh Tien come from?
All FDA import refusal data for Vinh Tien 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.