NextPharma SAS
⚠️ Moderate Risk
FEI: 3006330713 • Limay, Yvelines • FRANCE
FEI Number
3006330713
Location
Limay, Yvelines
Country
FRANCEAddress
17 Route De Meulan, , Limay, Yvelines, France
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
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/15/2021 | 61HDY08PHTHALYLSULFACETAMIDE (ANTI-BACTERIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/31/2020 | 61MDY42LEVETIRACETAM (ANTI-CONVULSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/2/2013 | 63HIL99CATHARTIC N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is NextPharma SAS's FDA import refusal history?
NextPharma SAS (FEI: 3006330713) has 3 FDA import refusal record(s) in our database, spanning from 12/2/2013 to 1/15/2021.
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. NextPharma SAS's FEI number is 3006330713.
What types of violations has NextPharma SAS received?
NextPharma SAS has been cited for 1 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 NextPharma SAS come from?
All FDA import refusal data for NextPharma 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.