Emd Serono Canada
⚠️ Moderate Risk
FEI: 3007371071 • Edmonton, ALBERTA • CANADA
FEI Number
3007371071
Location
Edmonton, ALBERTA
Country
CANADAAddress
2011 94 Street N, , Edmonton, ALBERTA, 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
NO LICENSE
The article is subject to refusal of admission under section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it appears to be a biological product for which a biologics license is not in effect under the Public Health Service Act, Part F, Subpart 1-Biological Products, Section 351(a), and it is not the subject of an Investigational New Drug application that is in effect. Therefore, it appears to be a new drug under 201(p) of the FD&C Act that it is in violation of section 505(a) of the FD&C Act because it lacks a new drug approval and because it is misbranded under section 502(f)(1)of the FD&C Act because it fails to bear adequate directions for use
INSANITARY
The article is subject to refusal of admission pursuant to section 801(a)(3) in that the article appears to have been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/30/2012 | 57YL99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C. | New Orleans District Office (NOL-DO) | |
| 8/30/2012 | 57YL99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C. | New Orleans District Office (NOL-DO) | |
| 8/30/2012 | 57YL99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C. | New Orleans District Office (NOL-DO) | |
| 8/30/2012 | 57YL99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C. | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Emd Serono Canada's FDA import refusal history?
Emd Serono Canada (FEI: 3007371071) has 4 FDA import refusal record(s) in our database, spanning from 8/30/2012 to 8/30/2012.
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. Emd Serono Canada's FEI number is 3007371071.
What types of violations has Emd Serono Canada received?
Emd Serono 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 Emd Serono Canada come from?
All FDA import refusal data for Emd Serono 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.