Sofradim Production
⚠️ Moderate Risk
FEI: 3003521774 • Trevoux, AIN • FRANCE
FEI Number
3003521774
Location
Trevoux, AIN
Country
FRANCEAddress
116 Avenue De Formans, , Trevoux, AIN, 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).
INVDEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a device for investigational use for which no exemption has been granted as prescribed by Section 520(g)
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/16/2023 | 79FTLMESH, SURGICAL, POLYMERIC | 341REGISTERED | Division of Northeast Imports (DNEI) |
| 10/24/2005 | 79MCZSUTURE REMOVAL KIT | 3081INVDEVICE | New Orleans District Office (NOL-DO) |
| 9/15/2005 | 89MPZIMPLANT, RESORBABLE BOVINE COLLAGEN, MENISCAL REPAIR | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/15/2005 | 79NBESEALANT, POLYMERIZING | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Sofradim Production's FDA import refusal history?
Sofradim Production (FEI: 3003521774) has 4 FDA import refusal record(s) in our database, spanning from 9/15/2005 to 8/16/2023.
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. Sofradim Production's FEI number is 3003521774.
What types of violations has Sofradim Production received?
Sofradim Production has been cited for 3 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 Sofradim Production come from?
All FDA import refusal data for Sofradim Production 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.