Becton Dickinson And Company
⚠️ Moderate Risk
FEI: 1911916 • Columbus, NE • UNITED STATES
FEI Number
1911916
Location
Columbus, NE
Country
UNITED STATESAddress
2153 12th Ave, , Columbus, NE, 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
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).
DV QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
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).
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/29/2025 | 80FMINEEDLE, HYPODERMIC, SINGLE LUMEN | Division of Northern Border Imports (DNBI) | |
| 2/29/2024 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 341REGISTERED | Division of Northern Border Imports (DNBI) |
| 2/29/2024 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 341REGISTERED | Division of Northern Border Imports (DNBI) |
| 2/29/2024 | 80FMINEEDLE, HYPODERMIC, SINGLE LUMEN | 341REGISTERED | Division of Northern Border Imports (DNBI) |
| 7/14/2022 | 80NGTDEVICE, FLUSH, VASCULAR ACCESS | Division of Southeast Imports (DSEI) | |
| 1/29/2019 | 80FMFSYRINGE, PISTON | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 1/29/2019 | 80FMFSYRINGE, PISTON | 479DV QUALITY | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is Becton Dickinson And Company's FDA import refusal history?
Becton Dickinson And Company (FEI: 1911916) has 7 FDA import refusal record(s) in our database, spanning from 1/29/2019 to 5/29/2025.
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 And Company's FEI number is 1911916.
What types of violations has Becton Dickinson And Company received?
Becton Dickinson And Company 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 Becton Dickinson And Company come from?
All FDA import refusal data for Becton Dickinson And Company 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.