Australian Pharmaceutical Manufacturers Pty Ltd
⚠️ Moderate Risk
FEI: 3009621129 • Mulgrave, Victoria • AUSTRALIA
FEI Number
3009621129
Location
Mulgrave, Victoria
Country
AUSTRALIAAddress
25 Pickering Road, , Mulgrave, Victoria, 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).
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.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/30/2012 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Chicago District Office (CHI-DO) | |
| 7/30/2012 | 66VBO99MISCELLANEOUS PATENT MEDICINES, ETC. | Chicago District Office (CHI-DO) | |
| 7/30/2012 | 66VCH99MISCELLANEOUS PATENT MEDICINES, ETC. | Chicago District Office (CHI-DO) | |
| 7/30/2012 | 66VCC99MISCELLANEOUS PATENT MEDICINES, ETC. | Chicago District Office (CHI-DO) | |
| 1/6/2012 | 54YBA99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 482NUTRIT LBL | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Australian Pharmaceutical Manufacturers Pty Ltd's FDA import refusal history?
Australian Pharmaceutical Manufacturers Pty Ltd (FEI: 3009621129) has 5 FDA import refusal record(s) in our database, spanning from 1/6/2012 to 7/30/2012.
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. Australian Pharmaceutical Manufacturers Pty Ltd's FEI number is 3009621129.
What types of violations has Australian Pharmaceutical Manufacturers Pty Ltd received?
Australian Pharmaceutical Manufacturers Pty Ltd has been cited for 5 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 Australian Pharmaceutical Manufacturers Pty Ltd come from?
All FDA import refusal data for Australian Pharmaceutical Manufacturers 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.