Pharma Cosmetics Pty Ltd
⚠️ Moderate Risk
FEI: 3006985012 • Silverwater, New South Wales • AUSTRALIA
FEI Number
3006985012
Location
Silverwater, New South Wales
Country
AUSTRALIAAddress
Unit 5 24 - 28 Skarratt Street N, , Silverwater, 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).
COL ADDED
The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).
N-RX INACT
The article appears to be a nonprescription drug and fails to bear the established name of each inactive ingredient in alphabetical order on the outside container of the retail package.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/14/2012 | 53CC99OTHER EYE MAKEUP PREPARATIONS, N.E.C. | 475COSMETLBLG | New Orleans District Office (NOL-DO) |
| 10/17/2009 | 66PBJ07OXYBENZONE (ULTRAVIOLET SCREEN/SUNSCREEN) | New Orleans District Office (NOL-DO) | |
| 10/17/2009 | 66PBJ07OXYBENZONE (ULTRAVIOLET SCREEN/SUNSCREEN) | New Orleans District Office (NOL-DO) | |
| 10/17/2009 | 66PBY07OXYBENZONE (ULTRAVIOLET SCREEN/SUNSCREEN) | New Orleans District Office (NOL-DO) | |
| 10/17/2009 | 66PBY07OXYBENZONE (ULTRAVIOLET SCREEN/SUNSCREEN) | New Orleans District Office (NOL-DO) | |
| 10/17/2009 | 66PBY07OXYBENZONE (ULTRAVIOLET SCREEN/SUNSCREEN) | New Orleans District Office (NOL-DO) | |
| 10/17/2009 | 66PBY07OXYBENZONE (ULTRAVIOLET SCREEN/SUNSCREEN) | New Orleans District Office (NOL-DO) | |
| 10/17/2009 | 66PBY07OXYBENZONE (ULTRAVIOLET SCREEN/SUNSCREEN) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 4/18/2007 | 53RD12SKIN CARE PREPARATIONS, COSMETIC PRODUCTS CONTAINING ANIMAL BY-PRODUCTS (BOVINE) | 475COSMETLBLG | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Pharma Cosmetics Pty Ltd's FDA import refusal history?
Pharma Cosmetics Pty Ltd (FEI: 3006985012) has 9 FDA import refusal record(s) in our database, spanning from 4/18/2007 to 9/14/2012.
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. Pharma Cosmetics Pty Ltd's FEI number is 3006985012.
What types of violations has Pharma Cosmetics Pty Ltd received?
Pharma Cosmetics Pty Ltd has been cited for 4 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 Pharma Cosmetics Pty Ltd come from?
All FDA import refusal data for Pharma Cosmetics 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.