Mayne Pharma International PTY LTD
⚠️ Moderate Risk
FEI: 3004090027 • Salisbury South, South Australia • AUSTRALIA
FEI Number
3004090027
Location
Salisbury South, South Australia
Country
AUSTRALIAAddress
1538 Main North Rd, , Salisbury South, South Australia, 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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/20/2020 | 66VDB99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 3/14/2019 | 65VCY13CLOZAPINE (SEDATIVE) | Division of Southeast Imports (DSEI) | |
| 3/2/2017 | 56IIS25ERYTHROMYCIN ETHYLSUCCINATE (MACROLIDES) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Mayne Pharma International PTY LTD's FDA import refusal history?
Mayne Pharma International PTY LTD (FEI: 3004090027) has 3 FDA import refusal record(s) in our database, spanning from 3/2/2017 to 7/20/2020.
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. Mayne Pharma International PTY LTD's FEI number is 3004090027.
What types of violations has Mayne Pharma International PTY LTD received?
Mayne Pharma International 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 Mayne Pharma International PTY LTD come from?
All FDA import refusal data for Mayne Pharma International 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.