Catalent France Beinheim SA
⚠️ High Risk
FEI: 3002808036 • Beinheim, Bas-Rhin • FRANCE
FEI Number
3002808036
Location
Beinheim, Bas-Rhin
Country
FRANCEAddress
74 Rue Principale, , Beinheim, Bas-Rhin, France
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).
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.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/24/2025 | 64XDA11ISOTRETINOIN (KERATOLYTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/22/2018 | 61WCH18MICONAZOLE NITRATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 1/22/2018 | 61WCH18MICONAZOLE NITRATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 1/22/2018 | 61WCH18MICONAZOLE NITRATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/9/2016 | 64XCB11ISOTRETINOIN (KERATOLYTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/18/2016 | 61WAJ18MICONAZOLE NITRATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | Division of Northeast Imports (DNEI) | |
| 4/9/2015 | 61WAY18MICONAZOLE NITRATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 4/9/2015 | 61WAY18MICONAZOLE NITRATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 4/9/2015 | 61WAY17MEPARTRICIN (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 4/9/2015 | 61WAY18MICONAZOLE NITRATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 4/9/2015 | 61WAY18MICONAZOLE NITRATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 8/30/2006 | 64XCF11ISOTRETINOIN (KERATOLYTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Catalent France Beinheim SA's FDA import refusal history?
Catalent France Beinheim SA (FEI: 3002808036) has 12 FDA import refusal record(s) in our database, spanning from 8/30/2006 to 9/24/2025.
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. Catalent France Beinheim SA's FEI number is 3002808036.
What types of violations has Catalent France Beinheim SA received?
Catalent France Beinheim SA 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 Catalent France Beinheim SA come from?
All FDA import refusal data for Catalent France Beinheim 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.