T.O.W.O
⚠️ Moderate Risk
FEI: 3009745164 • Port-Au-Prince, ouest • HAITI
FEI Number
3009745164
Location
Port-Au-Prince, ouest
Country
HAITIAddress
Butte Boyer Crois Des Mission 17, , Port-Au-Prince, ouest, Haiti
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).
FILTHY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/18/2021 | 61XCY14CYPROHEPTADINE HCL (ANTI-HISTAMINIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/18/2021 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/18/2021 | 61XCY14CYPROHEPTADINE HCL (ANTI-HISTAMINIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/1/2012 | 02YGT99MILLED GRAIN PRODUCTS, N.E.C. | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is T.O.W.O's FDA import refusal history?
T.O.W.O (FEI: 3009745164) has 4 FDA import refusal record(s) in our database, spanning from 11/1/2012 to 10/18/2021.
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. T.O.W.O's FEI number is 3009745164.
What types of violations has T.O.W.O received?
T.O.W.O has been cited for 3 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 T.O.W.O come from?
All FDA import refusal data for T.O.W.O 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.