Damis Maxaint
⚠️ Moderate Risk
FEI: 3007709787 • Port-Au-Prince, ouest • HAITI
FEI Number
3007709787
Location
Port-Au-Prince, ouest
Country
HAITIAddress
Ruelle Pescail 26, , 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
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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).
COUMARIN
The article appears to bear or contain Coumarin, a poisonous or deleterious substance, which may render it injurious to health.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/26/2011 | 28CGT51VANILLA, NATURAL EXTRACT OR FLAVOR (SPICE) | 2080COUMARIN | Florida District Office (FLA-DO) |
| 9/1/2009 | 63VJU02HYDROQUINONE (DEPIGMENTOR) | Florida District Office (FLA-DO) | |
| 9/1/2009 | 63VJU02HYDROQUINONE (DEPIGMENTOR) | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Damis Maxaint's FDA import refusal history?
Damis Maxaint (FEI: 3007709787) has 3 FDA import refusal record(s) in our database, spanning from 9/1/2009 to 1/26/2011.
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. Damis Maxaint's FEI number is 3007709787.
What types of violations has Damis Maxaint received?
Damis Maxaint 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 Damis Maxaint come from?
All FDA import refusal data for Damis Maxaint 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.