Activ Pharmaceuticals Pty Ltd.
⚠️ Moderate Risk
FEI: 3008232399 • Smeaton Grange, New South Wales • AUSTRALIA
FEI Number
3008232399
Location
Smeaton Grange, New South Wales
Country
AUSTRALIAAddress
2 Blackmore Rd, , Smeaton Grange, 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
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).
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 |
|---|---|---|---|
| 4/18/2019 | 60LBJ99ANALGESIC, N.E.C. | Division of Northern Border Imports (DNBI) | |
| 10/17/2009 | 66PBY07OXYBENZONE (ULTRAVIOLET SCREEN/SUNSCREEN) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 10/17/2009 | 66PBY07OXYBENZONE (ULTRAVIOLET SCREEN/SUNSCREEN) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Activ Pharmaceuticals Pty Ltd.'s FDA import refusal history?
Activ Pharmaceuticals Pty Ltd. (FEI: 3008232399) has 3 FDA import refusal record(s) in our database, spanning from 10/17/2009 to 4/18/2019.
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. Activ Pharmaceuticals Pty Ltd.'s FEI number is 3008232399.
What types of violations has Activ Pharmaceuticals Pty Ltd. received?
Activ Pharmaceuticals Pty Ltd. 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 Activ Pharmaceuticals Pty Ltd. come from?
All FDA import refusal data for Activ Pharmaceuticals Pty Ltd. 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.