AX Pharmaceutical Corporation
⚠️ Moderate Risk
FEI: 3010738198 • Concord, Ontario • CANADA
FEI Number
3010738198
Location
Concord, Ontario
Country
CANADAAddress
100 Tesma Way Unit 8, , Concord, 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
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/20/2022 | 64GIY13ESTRADIOL VALERATE (ESTROGEN) | Division of Southeast Imports (DSEI) | |
| 6/11/2018 | 62JQS14PERGOLIDE MESYLATE (ANTI-PARKINSONIAN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/11/2018 | 62JQS14PERGOLIDE MESYLATE (ANTI-PARKINSONIAN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/11/2018 | 64UIY02ACARBOSE (INHIBITOR (DECARBOXYLASE)) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is AX Pharmaceutical Corporation's FDA import refusal history?
AX Pharmaceutical Corporation (FEI: 3010738198) has 4 FDA import refusal record(s) in our database, spanning from 6/11/2018 to 5/20/2022.
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. AX Pharmaceutical Corporation's FEI number is 3010738198.
What types of violations has AX Pharmaceutical Corporation received?
AX Pharmaceutical Corporation 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 AX Pharmaceutical Corporation come from?
All FDA import refusal data for AX Pharmaceutical Corporation 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.