Septodont Ou Septodont SAS Ou Specialites Septodont
⚠️ Moderate Risk
FEI: 1000477999 • St Maur Des Fosses, Ile de France • FRANCE
FEI Number
1000477999
Location
St Maur Des Fosses, Ile de France
Country
FRANCEAddress
58 Rue Du Pont De Creteil, , St Maur Des Fosses, Ile de France, 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
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).
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.
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
DE/RX KIT
The article appears to be a combination medical device/prescription drug kit for which the prescription drug component was manufactured in the U.S., is offered for import by other than the manufacturer, and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
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 |
|---|---|---|---|
| 4/16/2025 | 76OLRORAL WOUND DRESSING | Division of West Coast Imports (DWCI) | |
| 3/9/2023 | 66YDY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/28/2022 | 76OLRORAL WOUND DRESSING | Division of Southeast Imports (DSEI) | |
| 10/4/2013 | 76LPGMATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Septodont Ou Septodont SAS Ou Specialites Septodont's FDA import refusal history?
Septodont Ou Septodont SAS Ou Specialites Septodont (FEI: 1000477999) has 4 FDA import refusal record(s) in our database, spanning from 10/4/2013 to 4/16/2025.
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. Septodont Ou Septodont SAS Ou Specialites Septodont's FEI number is 1000477999.
What types of violations has Septodont Ou Septodont SAS Ou Specialites Septodont received?
Septodont Ou Septodont SAS Ou Specialites Septodont has been cited for 6 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 Septodont Ou Septodont SAS Ou Specialites Septodont come from?
All FDA import refusal data for Septodont Ou Septodont SAS Ou Specialites Septodont 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.