Becton Dickinson & Co., Ltd.
⚠️ Moderate Risk
FEI: 3002809439 • Dublin • IRELAND
FEI Number
3002809439
Location
Dublin
Country
IRELANDAddress
Dun Laoghaire, Pottery Road, Dublin, , Ireland
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
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.
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 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.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
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).
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/28/2025 | 80FMINEEDLE, HYPODERMIC, SINGLE LUMEN | Division of Southeast Imports (DSEI) | |
| 9/22/2023 | 80FMINEEDLE, HYPODERMIC, SINGLE LUMEN | Division of Southeast Imports (DSEI) | |
| 9/15/2023 | 80FMINEEDLE, HYPODERMIC, SINGLE LUMEN | Division of Southeast Imports (DSEI) | |
| 3/23/2021 | 80FMINEEDLE, HYPODERMIC, SINGLE LUMEN | Division of Northeast Imports (DNEI) | |
| 3/19/2021 | 80FMINEEDLE, HYPODERMIC, SINGLE LUMEN | Division of Northern Border Imports (DNBI) | |
| 3/19/2021 | 80FMINEEDLE, HYPODERMIC, SINGLE LUMEN | Division of Northern Border Imports (DNBI) | |
| 2/8/2016 | 80FMINEEDLE, HYPODERMIC, SINGLE LUMEN | 341REGISTERED | Philadelphia District Office (PHI-DO) |
| 2/22/2005 | 80KZHINTRODUCER, SYRINGE NEEDLE | New England District Office (NWE-DO) | |
| 2/22/2005 | 80KZHINTRODUCER, SYRINGE NEEDLE | New England District Office (NWE-DO) |
Frequently Asked Questions
What is Becton Dickinson & Co., Ltd.'s FDA import refusal history?
Becton Dickinson & Co., Ltd. (FEI: 3002809439) has 9 FDA import refusal record(s) in our database, spanning from 2/22/2005 to 4/28/2025.
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. Becton Dickinson & Co., Ltd.'s FEI number is 3002809439.
What types of violations has Becton Dickinson & Co., Ltd. received?
Becton Dickinson & Co., Ltd. has been cited for 8 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 & Co., Ltd. come from?
All FDA import refusal data for Becton Dickinson & Co., Ltd. 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.