BECKTON DICKINSON-CANADA

⚠️ Moderate Risk

FEI: 3012393469 • Mississauga, Ontario • CANADA

FEI

FEI Number

3012393469

📍

Location

Mississauga, Ontario

🇨🇦

Country

CANADA

🏢

Address

100-2100 Derry Rd W, , Mississauga, Ontario, Canada

Moderate Risk

FDA Import Risk Assessment

48.7

LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

Total Refusals

Unique Violations

3/2/2018

Latest Refusal

8/26/2016

Earliest Refusal

Score Breakdown

Violation Severity

56.6×40%

Refusal Volume

53.6×30%

Recency

0.0×20%

Frequency

100.0×10%

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

Violation Summary

328027×

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.

11826×

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).

50826×

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
3/2/2018	75OYJDNA SPECIMEN COLLECTION, SALIVA	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
2/14/2018	75OYJDNA SPECIMEN COLLECTION, SALIVA	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
2/14/2018	75OYJDNA SPECIMEN COLLECTION, SALIVA	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
2/14/2018	75OYJDNA SPECIMEN COLLECTION, SALIVA	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
10/31/2017	75OYJDNA SPECIMEN COLLECTION, SALIVA	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
3/23/2017	75OYJDNA SPECIMEN COLLECTION, SALIVA	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Detroit District Office (DET-DO)
3/23/2017	75OYJDNA SPECIMEN COLLECTION, SALIVA	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Detroit District Office (DET-DO)
2/28/2017	75OYJDNA SPECIMEN COLLECTION, SALIVA	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
2/22/2017	88NJTIMMUNOHISTOCHEMISTRY REAGENTS AND KITS	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
2/13/2017	75OYJDNA SPECIMEN COLLECTION, SALIVA	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Detroit District Office (DET-DO)
2/13/2017	75OYJDNA SPECIMEN COLLECTION, SALIVA	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Detroit District Office (DET-DO)
2/13/2017	75OYJDNA SPECIMEN COLLECTION, SALIVA	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Detroit District Office (DET-DO)
1/24/2017	75OYJDNA SPECIMEN COLLECTION, SALIVA	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
1/24/2017	75OYJDNA SPECIMEN COLLECTION, SALIVA	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Detroit District Office (DET-DO)
1/24/2017	75OYJDNA SPECIMEN COLLECTION, SALIVA	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Detroit District Office (DET-DO)
1/24/2017	75OYJDNA SPECIMEN COLLECTION, SALIVA	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Detroit District Office (DET-DO)
1/23/2017	83LIODEVICE, SPECIMEN COLLECTION	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Detroit District Office (DET-DO)
1/17/2017	75OYJDNA SPECIMEN COLLECTION, SALIVA	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Detroit District Office (DET-DO)
1/17/2017	75OYJDNA SPECIMEN COLLECTION, SALIVA	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Detroit District Office (DET-DO)
12/30/2016	75OYJDNA SPECIMEN COLLECTION, SALIVA	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
12/9/2016	75OYJDNA SPECIMEN COLLECTION, SALIVA	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
12/9/2016	75OYJDNA SPECIMEN COLLECTION, SALIVA	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
11/16/2016	75OYJDNA SPECIMEN COLLECTION, SALIVA	3280FRNMFGREG	Division of Southeast Imports (DSEI)
8/26/2016	75OYJDNA SPECIMEN COLLECTION, SALIVA	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Detroit District Office (DET-DO)
8/26/2016	75OYJDNA SPECIMEN COLLECTION, SALIVA	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Detroit District Office (DET-DO)
8/26/2016	83LIODEVICE, SPECIMEN COLLECTION	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Detroit District Office (DET-DO)
8/26/2016	75OYJDNA SPECIMEN COLLECTION, SALIVA	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Detroit District Office (DET-DO)

Frequently Asked Questions

What is BECKTON DICKINSON-CANADA's FDA import refusal history?

BECKTON DICKINSON-CANADA (FEI: 3012393469) has 27 FDA import refusal record(s) in our database, spanning from 8/26/2016 to 3/2/2018.

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. BECKTON DICKINSON-CANADA's FEI number is 3012393469.

What types of violations has BECKTON DICKINSON-CANADA received?

BECKTON DICKINSON-CANADA 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 BECKTON DICKINSON-CANADA come from?

All FDA import refusal data for BECKTON DICKINSON-CANADA 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.