Attix Pharmaceuticals Inc.
⚠️ Moderate Risk
FEI: 3008197162 • Toronto, Ontario • CANADA
FEI Number
3008197162
Location
Toronto, Ontario
Country
CANADAAddress
184 Front St E Unit 801, , Toronto, Ontario, 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
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.
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).
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/25/2013 | 60ELT01TRILOSTANE (ADRENOCORTICAL SUPPRESSANT | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 10/15/2013 | 65DCT06OXYTOCIN (INJECTION) (OXYTOCIC) | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 10/2/2013 | 60SAS21CISAPRIDE (ANTACID) | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 12/4/2012 | 64GCY07ESTRADIOL (ESTROGEN) | Cincinnati District Office (CIN-DO) | |
| 12/4/2012 | 64GCY22NYLESTRIOL (ESTROGEN) | Cincinnati District Office (CIN-DO) | |
| 3/1/2012 | 68YAY10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | New York District Office (NYK-DO) |
| 2/23/2009 | 66MIY83HYDROXYZINE HCL (TRANQUILIZER) | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 2/23/2009 | 64RQS99HORMONE N.E.C. | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 2/23/2009 | 64RCS18HUMAN GROWTH HORMONE (HORMONE) | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Attix Pharmaceuticals Inc.'s FDA import refusal history?
Attix Pharmaceuticals Inc. (FEI: 3008197162) has 9 FDA import refusal record(s) in our database, spanning from 2/23/2009 to 10/25/2013.
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. Attix Pharmaceuticals Inc.'s FEI number is 3008197162.
What types of violations has Attix Pharmaceuticals Inc. received?
Attix Pharmaceuticals Inc. 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 Attix Pharmaceuticals Inc. come from?
All FDA import refusal data for Attix Pharmaceuticals 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.