Unite de Fabrication de Medicaments SA
⚠️ Moderate Risk
FEI: 3005004272 • Sousse, Sousse • TUNISIA
FEI Number
3005004272
Location
Sousse, Sousse
Country
TUNISIAAddress
Zone Industrielle, Kalaa El Kebira, Sousse, Sousse, Tunisia
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
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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).
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/14/2015 | 65FAK06WATER, PURIFIED (EYEWASH) | Division of Northeast Imports (DNEI) | |
| 1/13/2015 | 65F06WATER, PURIFIED (EYEWASH) | Division of Northeast Imports (DNEI) | |
| 7/3/2013 | 65FBK06WATER, PURIFIED (EYEWASH) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Unite de Fabrication de Medicaments SA's FDA import refusal history?
Unite de Fabrication de Medicaments SA (FEI: 3005004272) has 3 FDA import refusal record(s) in our database, spanning from 7/3/2013 to 1/14/2015.
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. Unite de Fabrication de Medicaments SA's FEI number is 3005004272.
What types of violations has Unite de Fabrication de Medicaments SA received?
Unite de Fabrication de Medicaments SA has been cited for 6 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 Unite de Fabrication de Medicaments SA come from?
All FDA import refusal data for Unite de Fabrication de Medicaments SA 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.