Itf Co Ltd
⚠️ Moderate Risk
FEI: 3010300155 • Ho Chi Minh • VIETNAM
FEI Number
3010300155
Location
Ho Chi Minh
Country
VIETNAMAddress
7/2 Ngueyn Canh Di Str, , Ho Chi Minh, , 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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/20/2013 | 60LCA69TRAMADOL HCL (ANALGESIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 8/20/2013 | 60LDH57PROPOXYPHENE NAPSYLATE (ANALGESIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 8/15/2013 | 66VAA99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Itf Co Ltd's FDA import refusal history?
Itf Co Ltd (FEI: 3010300155) has 3 FDA import refusal record(s) in our database, spanning from 8/15/2013 to 8/20/2013.
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. Itf Co Ltd's FEI number is 3010300155.
What types of violations has Itf Co Ltd received?
Itf Co 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 Itf Co Ltd come from?
All FDA import refusal data for Itf Co 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.