Besins Manufacturing Belgium
⚠️ High Risk
FEI: 3010992983 • Drogenbos, Vlaams-Brabant • BELGIUM
FEI Number
3010992983
Location
Drogenbos, Vlaams-Brabant
Country
BELGIUMAddress
Groot Bygaerdenstraat 128, , Drogenbos, Vlaams-Brabant, Belgium
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/2/2026 | 65JCA31PROGESTERONE (PROGESTIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/2/2026 | 64GCL07ESTRADIOL (ESTROGEN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/7/2024 | 64GCY07ESTRADIOL (ESTROGEN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/30/2018 | 65JCY31PROGESTERONE (PROGESTIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/14/2007 | 65JCH31PROGESTERONE (PROGESTIN) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Besins Manufacturing Belgium's FDA import refusal history?
Besins Manufacturing Belgium (FEI: 3010992983) has 5 FDA import refusal record(s) in our database, spanning from 4/14/2007 to 1/2/2026.
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. Besins Manufacturing Belgium's FEI number is 3010992983.
What types of violations has Besins Manufacturing Belgium received?
Besins Manufacturing Belgium 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 Besins Manufacturing Belgium come from?
All FDA import refusal data for Besins Manufacturing Belgium 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.