Mathieu Gisele
⚠️ Moderate Risk
FEI: 3003519052 • Port-Au-Prince, ouest • HAITI
FEI Number
3003519052
Location
Port-Au-Prince, ouest
Country
HAITIAddress
Bizoton 53 No 10 Bis, , 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).
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).
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/4/2004 | 62CDL41MINOXIDIL (ANTI-HYPERTENSIVE) | Florida District Office (FLA-DO) | |
| 5/4/2004 | 61XPL14CYPROHEPTADINE HCL (ANTI-HISTAMINIC) | Florida District Office (FLA-DO) | |
| 5/4/2004 | 53JD03DOUCHES (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 471CSTIC LBLG | Florida District Office (FLA-DO) |
| 12/15/2003 | 63RBY99DENTAL CARIES PROPHYLACTIC N.E.C. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Mathieu Gisele's FDA import refusal history?
Mathieu Gisele (FEI: 3003519052) has 4 FDA import refusal record(s) in our database, spanning from 12/15/2003 to 5/4/2004.
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. Mathieu Gisele's FEI number is 3003519052.
What types of violations has Mathieu Gisele received?
Mathieu Gisele 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 Mathieu Gisele come from?
All FDA import refusal data for Mathieu Gisele 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.