Wyeth-Ayerst Canada Inc
⚠️ Moderate Risk
FEI: 1000479100 • St Laurent, Quebec • CANADA
FEI Number
1000479100
Location
St Laurent, Quebec
Country
CANADAAddress
1765 Cote Vertu, , St Laurent, 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/1/2013 | 62GCH41IBUPROFEN (ANTI-INFLAMMATORY) | New Orleans District Office (NOL-DO) | |
| 12/11/2007 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/5/2006 | 64GCB16CONJUGATED ESTROGENS (ESTROGEN) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/1/2004 | 65JCA29NORGESTREL (PROGESTIN) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/6/2002 | 66VCE99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Wyeth-Ayerst Canada Inc's FDA import refusal history?
Wyeth-Ayerst Canada Inc (FEI: 1000479100) has 5 FDA import refusal record(s) in our database, spanning from 11/6/2002 to 2/1/2013.
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. Wyeth-Ayerst Canada Inc's FEI number is 1000479100.
What types of violations has Wyeth-Ayerst Canada Inc received?
Wyeth-Ayerst Canada Inc has been cited for 2 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 Wyeth-Ayerst Canada Inc come from?
All FDA import refusal data for Wyeth-Ayerst 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.