Vitex Pharmaceuticals Pty Ltd.
⚠️ Moderate Risk
FEI: 3013081713 • Eastern Creek, New South Wales • AUSTRALIA
FEI Number
3013081713
Location
Eastern Creek, New South Wales
Country
AUSTRALIAAddress
4 Alspec Pl, , Eastern Creek, 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
DIETARYLBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.
HEALTH C
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 bears an unauthorized nutrient content/health claim.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/31/2023 | 54FBC19MAGNOLIA (HERBAL & BOTANICALS, NOT TEAS) | Division of Northern Border Imports (DNBI) | |
| 3/31/2023 | 54FBC19MAGNOLIA (HERBAL & BOTANICALS, NOT TEAS) | Division of Northern Border Imports (DNBI) | |
| 3/31/2023 | 54EBB54PENNY ROYAL (HERBAL & BOTANICAL TEAS) | Division of Northern Border Imports (DNBI) | |
| 3/31/2023 | 54EBB54PENNY ROYAL (HERBAL & BOTANICAL TEAS) | Division of Northern Border Imports (DNBI) | |
| 3/31/2023 | 54ACR90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | Division of Northern Border Imports (DNBI) | |
| 3/31/2023 | 54ACR90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | Division of Northern Border Imports (DNBI) | |
| 3/31/2023 | 54ACR90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Vitex Pharmaceuticals Pty Ltd.'s FDA import refusal history?
Vitex Pharmaceuticals Pty Ltd. (FEI: 3013081713) has 7 FDA import refusal record(s) in our database, spanning from 3/31/2023 to 3/31/2023.
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. Vitex Pharmaceuticals Pty Ltd.'s FEI number is 3013081713.
What types of violations has Vitex Pharmaceuticals Pty Ltd. received?
Vitex Pharmaceuticals 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 Vitex Pharmaceuticals Pty Ltd. come from?
All FDA import refusal data for Vitex Pharmaceuticals 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.