AUSTRALIAN HEALTH INDUSTRY CO.
⚠️ High Risk
FEI: 3016713799 • Villawood, New South Wales • AUSTRALIA
FEI Number
3016713799
Location
Villawood, New South Wales
Country
AUSTRALIAAddress
17 Birmingham Ave, , Villawood, New South Wales, Australia
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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 |
|---|---|---|---|
| 8/5/2021 | 53LY08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/19/2021 | 53LD08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/2/2021 | 53LC08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 1/27/2021 | 53LF99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 1/27/2021 | 53LF99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 1/27/2021 | 53LF99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 1/27/2021 | 53LF99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 1/27/2021 | 53LF99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is AUSTRALIAN HEALTH INDUSTRY CO.'s FDA import refusal history?
AUSTRALIAN HEALTH INDUSTRY CO. (FEI: 3016713799) has 8 FDA import refusal record(s) in our database, spanning from 1/27/2021 to 8/5/2021.
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 HEALTH INDUSTRY CO.'s FEI number is 3016713799.
What types of violations has AUSTRALIAN HEALTH INDUSTRY CO. received?
AUSTRALIAN HEALTH INDUSTRY CO. has been cited for 1 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 HEALTH INDUSTRY CO. come from?
All FDA import refusal data for AUSTRALIAN HEALTH INDUSTRY CO. 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.