Becton, Dickinson and Company
⚠️ Moderate Risk
FEI: 1917413 • Broken Bow, NE • UNITED STATES
FEI Number
1917413
Location
Broken Bow, NE
Country
UNITED STATESAddress
150 S 1st Ave, , Broken Bow, 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
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
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 |
|---|---|---|---|
| 10/5/2020 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 8/27/2019 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 8/27/2019 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 3/27/2019 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 3/27/2019 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Becton, Dickinson and Company's FDA import refusal history?
Becton, Dickinson and Company (FEI: 1917413) has 5 FDA import refusal record(s) in our database, spanning from 3/27/2019 to 10/5/2020.
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 1917413.
What types of violations has Becton, Dickinson and Company received?
Becton, Dickinson and Company 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 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.