Opella Healthcare International SAS
⚠️ High Risk
FEI: 3003492806 • Compiegne, Oise • FRANCE
FEI Number
3003492806
Location
Compiegne, Oise
Country
FRANCEAddress
56 Route De Choisy, , Compiegne, Oise, 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/27/2024 | 60LCB84LEFLUNOMIDE (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/18/2024 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/8/2023 | 64BCY24FUROSEMIDE (DIURETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/7/2023 | 61PCA99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/20/2013 | 61ECS06FEXOFENADINE HCL (ANTI-ASTHMATIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 8/27/2008 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 8/1/2007 | 62GCB99ANTI-INFLAMMATORY N.E.C. | New York District Office (NYK-DO) | |
| 12/30/2003 | 62GDO17DESOXIMETASONE (ANTI-INFLAMMATORY) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Opella Healthcare International SAS's FDA import refusal history?
Opella Healthcare International SAS (FEI: 3003492806) has 8 FDA import refusal record(s) in our database, spanning from 12/30/2003 to 12/27/2024.
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. Opella Healthcare International SAS's FEI number is 3003492806.
What types of violations has Opella Healthcare International SAS received?
Opella Healthcare International SAS 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 Opella Healthcare International SAS come from?
All FDA import refusal data for Opella Healthcare International SAS 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.