BioMetric Imaging/A Becton Dickson & Co
⚠️ Moderate Risk
FEI: 1000221411 • Franklin Lakes, NJ • UNITED STATES
FEI Number
1000221411
Location
Franklin Lakes, NJ
Country
UNITED STATESAddress
1 Becton Dr, , Franklin Lakes, NJ, United States
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).
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 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 |
|---|---|---|---|
| 7/20/2022 | 80FMFSYRINGE, PISTON | Division of Southeast Imports (DSEI) | |
| 3/28/2019 | 80KZHINTRODUCER, SYRINGE NEEDLE | Division of Southeast Imports (DSEI) | |
| 7/3/2018 | 75GIMTUBES, VACUUM SAMPLE, WITH ANTICOAGULANT | Division of Southeast Imports (DSEI) | |
| 7/3/2018 | 75GIMTUBES, VACUUM SAMPLE, WITH ANTICOAGULANT | Division of Southeast Imports (DSEI) | |
| 7/3/2018 | 75GIMTUBES, VACUUM SAMPLE, WITH ANTICOAGULANT | Division of Southeast Imports (DSEI) | |
| 7/3/2018 | 75PJEBLOOD/PLASMA COLLECTION DEVICE FOR DNA TESTING | Division of Southeast Imports (DSEI) | |
| 7/3/2018 | 75PJEBLOOD/PLASMA COLLECTION DEVICE FOR DNA TESTING | Division of Southeast Imports (DSEI) | |
| 2/10/2012 | 80FMFSYRINGE, PISTON | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 2/6/2012 | 80FMINEEDLE, HYPODERMIC, SINGLE LUMEN | 344WARNINGS | New York District Office (NYK-DO) |
| 2/6/2012 | 80FMINEEDLE, HYPODERMIC, SINGLE LUMEN | 344WARNINGS | New York District Office (NYK-DO) |
| 12/3/2010 | 80FMINEEDLE, HYPODERMIC, SINGLE LUMEN | 341REGISTERED | Florida District Office (FLA-DO) |
| 11/3/2010 | 80FMFSYRINGE, PISTON | 508NO 510(K) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is BioMetric Imaging/A Becton Dickson & Co's FDA import refusal history?
BioMetric Imaging/A Becton Dickson & Co (FEI: 1000221411) has 12 FDA import refusal record(s) in our database, spanning from 11/3/2010 to 7/20/2022.
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. BioMetric Imaging/A Becton Dickson & Co's FEI number is 1000221411.
What types of violations has BioMetric Imaging/A Becton Dickson & Co received?
BioMetric Imaging/A Becton Dickson & Co has been cited for 5 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 BioMetric Imaging/A Becton Dickson & Co come from?
All FDA import refusal data for BioMetric Imaging/A Becton Dickson & Co 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.