Becton Dickinson, S.A.
⚠️ Moderate Risk
FEI: 3003152976 • San Agustin Del Guadalix, Madrid • SPAIN
FEI Number
3003152976
Location
San Agustin Del Guadalix, Madrid
Country
SPAINAddress
Camino Valdeoliva S/N, , San Agustin Del Guadalix, Madrid, Spain
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).
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).
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 |
|---|---|---|---|
| 8/30/2024 | 80ONBCLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM | Division of Southeast Imports (DSEI) | |
| 2/8/2016 | 80FMFSYRINGE, PISTON | 341REGISTERED | Philadelphia District Office (PHI-DO) |
| 8/11/2004 | 79GBSCATHETER, VENTRICULAR, GENERAL & PLASTIC SURGERY | 118NOT LISTED | Baltimore District Office (BLT-DO) |
| 8/11/2004 | 79GBSCATHETER, VENTRICULAR, GENERAL & PLASTIC SURGERY | 118NOT LISTED | Baltimore District Office (BLT-DO) |
| 8/11/2004 | 79GBSCATHETER, VENTRICULAR, GENERAL & PLASTIC SURGERY | 118NOT LISTED | Baltimore District Office (BLT-DO) |
| 8/11/2004 | 79GBSCATHETER, VENTRICULAR, GENERAL & PLASTIC SURGERY | 118NOT LISTED | Baltimore District Office (BLT-DO) |
Frequently Asked Questions
What is Becton Dickinson, S.A.'s FDA import refusal history?
Becton Dickinson, S.A. (FEI: 3003152976) has 6 FDA import refusal record(s) in our database, spanning from 8/11/2004 to 8/30/2024.
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. Becton Dickinson, S.A.'s FEI number is 3003152976.
What types of violations has Becton Dickinson, S.A. received?
Becton Dickinson, S.A. 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 Becton Dickinson, S.A. come from?
All FDA import refusal data for Becton Dickinson, S.A. 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.