G&M Australian Cosmetics
⚠️ Moderate Risk
FEI: 3003351294 • Kirrawee, NSW • AUSTRALIA
FEI Number
3003351294
Location
Kirrawee, NSW
Country
AUSTRALIAAddress
Unit 5, 102 Bath Road, , Kirrawee, NSW, 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
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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).
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/4/2005 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 473LABELING | Minneapolis District Office (MIN-DO) |
| 5/4/2005 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 473LABELING | Minneapolis District Office (MIN-DO) |
| 5/4/2005 | 53YC99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 473LABELING | Minneapolis District Office (MIN-DO) |
| 5/4/2005 | 53YC99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 473LABELING | Minneapolis District Office (MIN-DO) |
| 5/4/2005 | 53GC05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | Minneapolis District Office (MIN-DO) | |
| 5/4/2005 | 64DBJ99EMOLLIENT, LUBRICANT, N.E.C. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 5/4/2005 | 62FBJ99ANTI-INFECTIVE, TOPICAL N.E.C. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 5/4/2005 | 64DBJ99EMOLLIENT, LUBRICANT, N.E.C. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 5/4/2005 | 62GBJ99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
Frequently Asked Questions
What is G&M Australian Cosmetics's FDA import refusal history?
G&M Australian Cosmetics (FEI: 3003351294) has 9 FDA import refusal record(s) in our database, spanning from 5/4/2005 to 5/4/2005.
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. G&M Australian Cosmetics's FEI number is 3003351294.
What types of violations has G&M Australian Cosmetics received?
G&M Australian Cosmetics 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 G&M Australian Cosmetics come from?
All FDA import refusal data for G&M Australian Cosmetics 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.