TP PHARMA
⚠️ High Risk
FEI: 3031696062 • Hanoi • VIETNAM
FEI Number
3031696062
Location
Hanoi
Country
VIETNAMAddress
No Nv1 Tan Trieu Commun, , Hanoi, , Vietnam
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
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/27/2024 | 33YVT99CANDY WITHOUT CHOCOLATE N.E.C. | Division of Southeast Imports (DSEI) | |
| 8/27/2024 | 54ACY02VITAMIN B1 (THIAMINE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/27/2024 | 54FCK16LICORICE (HERBAL & BOTANICALS, NOT TEAS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is TP PHARMA's FDA import refusal history?
TP PHARMA (FEI: 3031696062) has 3 FDA import refusal record(s) in our database, spanning from 8/27/2024 to 8/27/2024.
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. TP PHARMA's FEI number is 3031696062.
What types of violations has TP PHARMA received?
TP PHARMA 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 TP PHARMA come from?
All FDA import refusal data for TP PHARMA 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.