Aaxis Pacific
⚠️ Moderate Risk
FEI: 3005461786 • Seven Hills, New South Wales • AUSTRALIA
FEI Number
3005461786
Location
Seven Hills, New South Wales
Country
AUSTRALIAAddress
30-32 Foundry Rd, , Seven Hills, New South Wales, Australia
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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/6/2011 | 86LPNACCESSORIES TO CONTACT LENSES - CLEANING AND WETTING AGENTS | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 10/6/2011 | 86LPNACCESSORIES TO CONTACT LENSES - CLEANING AND WETTING AGENTS | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 3/23/2011 | 86LPNACCESSORIES TO CONTACT LENSES - CLEANING AND WETTING AGENTS | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Aaxis Pacific's FDA import refusal history?
Aaxis Pacific (FEI: 3005461786) has 3 FDA import refusal record(s) in our database, spanning from 3/23/2011 to 10/6/2011.
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. Aaxis Pacific's FEI number is 3005461786.
What types of violations has Aaxis Pacific received?
Aaxis Pacific 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 Aaxis Pacific come from?
All FDA import refusal data for Aaxis Pacific 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.