E-Z-EM Canada, Inc
⚠️ Moderate Risk
FEI: 3002808342 • Anjou, Quebec • CANADA
FEI Number
3002808342
Location
Anjou, Quebec
Country
CANADAAddress
11065 Louis-H.-La Fontaine Blvd, , Anjou, Quebec, Canada
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
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
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).
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
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 |
|---|---|---|---|
| 10/28/2019 | 63XCL40BARIUM SULFATE (DIAGNOSTIC AID) (DRUGS) | Division of Northern Border Imports (DNBI) | |
| 10/28/2019 | 63XCR40BARIUM SULFATE (DIAGNOSTIC AID) (DRUGS) | Division of Northern Border Imports (DNBI) | |
| 3/12/2012 | 63XCL40BARIUM SULFATE (DIAGNOSTIC AID) (DRUGS) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/12/2012 | 63XCL40BARIUM SULFATE (DIAGNOSTIC AID) (DRUGS) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/12/2012 | 63XCL40BARIUM SULFATE (DIAGNOSTIC AID) (DRUGS) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/23/2011 | 63XCL40BARIUM SULFATE (DIAGNOSTIC AID) (DRUGS) | New York District Office (NYK-DO) | |
| 12/7/2011 | 66YIY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 16DIRECTIONS | Seattle District Office (SEA-DO) |
| 8/29/2006 | 66PBJ07OXYBENZONE (ULTRAVIOLET SCREEN/SUNSCREEN) | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 8/26/2004 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 8/26/2004 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 8/26/2004 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New York District Office (NYK-DO) |
Frequently Asked Questions
What is E-Z-EM Canada, Inc's FDA import refusal history?
E-Z-EM Canada, Inc (FEI: 3002808342) has 11 FDA import refusal record(s) in our database, spanning from 8/26/2004 to 10/28/2019.
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. E-Z-EM Canada, Inc's FEI number is 3002808342.
What types of violations has E-Z-EM Canada, Inc received?
E-Z-EM Canada, Inc has been cited for 4 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 E-Z-EM Canada, Inc come from?
All FDA import refusal data for E-Z-EM Canada, Inc 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.