Wyeth Ayerst Laboratories
⚠️ High Risk
FEI: 3003250871 • Saint-Laurent, Quebec • CANADA
FEI Number
3003250871
Location
Saint-Laurent, Quebec
Country
CANADAAddress
1800 Thimens Blvd, , Saint-Laurent, Quebec, Canada
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/18/2008 | 65JDY29NORGESTREL (PROGESTIN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 1/18/2008 | 64NCA04FERROUS FUMARATE (HEMATINIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 1/18/2008 | 65JDY29NORGESTREL (PROGESTIN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/21/2007 | 64NCA04FERROUS FUMARATE (HEMATINIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/21/2007 | 65JDY29NORGESTREL (PROGESTIN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/21/2007 | 65JDY29NORGESTREL (PROGESTIN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/21/2007 | 65JDY29NORGESTREL (PROGESTIN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/21/2007 | 64NCA04FERROUS FUMARATE (HEMATINIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/21/2007 | 65JDY29NORGESTREL (PROGESTIN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/21/2007 | 65JDY29NORGESTREL (PROGESTIN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/21/2007 | 64NCA04FERROUS FUMARATE (HEMATINIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/21/2007 | 65JDY29NORGESTREL (PROGESTIN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/21/2007 | 64NCA04FERROUS FUMARATE (HEMATINIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/21/2007 | 65JDY29NORGESTREL (PROGESTIN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/21/2007 | 65JDY29NORGESTREL (PROGESTIN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/21/2007 | 65JDY29NORGESTREL (PROGESTIN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/21/2007 | 64NCA04FERROUS FUMARATE (HEMATINIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/21/2007 | 65JDY29NORGESTREL (PROGESTIN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/21/2007 | 64NCA04FERROUS FUMARATE (HEMATINIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/21/2007 | 65JDY29NORGESTREL (PROGESTIN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/21/2007 | 54BBY07IRON (MINERAL) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/21/2007 | 65JDY29NORGESTREL (PROGESTIN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/21/2007 | 65JDY29NORGESTREL (PROGESTIN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/21/2007 | 65JDY29NORGESTREL (PROGESTIN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/21/2007 | 65JDY29NORGESTREL (PROGESTIN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/21/2007 | 65JDY29NORGESTREL (PROGESTIN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/21/2007 | 65JDY29NORGESTREL (PROGESTIN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/21/2007 | 54BBY07IRON (MINERAL) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/21/2007 | 54BBY07IRON (MINERAL) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/21/2007 | 65JDY29NORGESTREL (PROGESTIN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/21/2007 | 65JDY29NORGESTREL (PROGESTIN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/21/2007 | 65JDY29NORGESTREL (PROGESTIN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/21/2007 | 65JDY29NORGESTREL (PROGESTIN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/21/2007 | 65JDY29NORGESTREL (PROGESTIN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/21/2007 | 65JDY29NORGESTREL (PROGESTIN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/21/2007 | 64NCA04FERROUS FUMARATE (HEMATINIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/21/2007 | 65JDY29NORGESTREL (PROGESTIN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 6/5/2007 | 65JDY29NORGESTREL (PROGESTIN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 6/5/2007 | 65JDY29NORGESTREL (PROGESTIN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 3/24/2006 | 61PIS99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 2/23/2006 | 61PIR99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 2/23/2006 | 61PIR99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Wyeth Ayerst Laboratories's FDA import refusal history?
Wyeth Ayerst Laboratories (FEI: 3003250871) has 42 FDA import refusal record(s) in our database, spanning from 2/23/2006 to 1/18/2008.
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 Laboratories's FEI number is 3003250871.
What types of violations has Wyeth Ayerst Laboratories received?
Wyeth Ayerst Laboratories has been cited for 1 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 Laboratories come from?
All FDA import refusal data for Wyeth Ayerst Laboratories 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.