Allergan Canada
⚠️ Moderate Risk
FEI: 1000493316 • Markham, ON • CANADA
FEI Number
1000493316
Location
Markham, ON
Country
CANADAAddress
110 Cochrane Drive, , Markham, ON, 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).
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
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).
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/20/2010 | 65QCK02BOTOX | Cincinnati District Office (CIN-DO) | |
| 12/21/2008 | 60CCY51TETRAHYDROZOLINE HCL (ADRENERGIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/10/2008 | 65QDK02BOTOX | New Orleans District Office (NOL-DO) | |
| 9/22/2008 | 65QCK02BOTOX | New Orleans District Office (NOL-DO) | |
| 1/6/2005 | 64LCP31FLUOROMETHOLONE (GLUCOCORTICOID) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/16/2004 | 61EDK10NEDOCROMIL SODIUM (ANTI-ASTHMATIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/13/2004 | 60XCK23TIMOLOL MALEATE (ANTI-ADRENERGIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/18/2003 | 57AY02BOTULISM ANTITOXIN | 71NO LICENSE | New Orleans District Office (NOL-DO) |
| 7/8/2003 | 53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 71NO LICENSE | New Orleans District Office (NOL-DO) |
| 5/1/2003 | 57YY99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C. | 27DRUG GMPS | Cincinnati District Office (CIN-DO) |
| 4/21/2003 | 57AY02BOTULISM ANTITOXIN | 71NO LICENSE | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Allergan Canada's FDA import refusal history?
Allergan Canada (FEI: 1000493316) has 11 FDA import refusal record(s) in our database, spanning from 4/21/2003 to 5/20/2010.
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. Allergan Canada's FEI number is 1000493316.
What types of violations has Allergan Canada received?
Allergan Canada has been cited for 6 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 Allergan Canada come from?
All FDA import refusal data for Allergan 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.