Becton Dickinson France SAS
⚠️ Moderate Risk
FEI: 1000173750 • Le Pont-De-Claix, Isere • FRANCE
FEI Number
1000173750
Location
Le Pont-De-Claix, Isere
Country
FRANCEAddress
11 Rue Aristide Berges, Bp 4, Le Pont-De-Claix, Isere, 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
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).
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).
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/9/2023 | 80KZHINTRODUCER, SYRINGE NEEDLE | Division of Southeast Imports (DSEI) | |
| 11/21/2018 | 80FMFSYRINGE, PISTON | 341REGISTERED | Division of Northeast Imports (DNEI) |
| 4/20/2017 | 79GEACANNULA, SURGICAL, GENERAL & PLASTIC SURGERY | 237NO PMA | Division of Northeast Imports (DNEI) |
| 12/17/2015 | 80MEGSYRINGE, ANTISTICK | 341REGISTERED | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Becton Dickinson France SAS's FDA import refusal history?
Becton Dickinson France SAS (FEI: 1000173750) has 4 FDA import refusal record(s) in our database, spanning from 12/17/2015 to 2/9/2023.
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. Becton Dickinson France SAS's FEI number is 1000173750.
What types of violations has Becton Dickinson France SAS received?
Becton Dickinson France SAS 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 Becton Dickinson France SAS come from?
All FDA import refusal data for Becton Dickinson France 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.