JSHEALTH
⚠️ Moderate Risk
FEI: 3019760048 • Prestons • AUSTRALIA
FEI Number
3019760048
Location
Prestons
Country
AUSTRALIAAddress
1a/5 35 Yarrunga Street, , Prestons, , 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.
DIETARY
The article purports to be or is represented for special dietary uses and its label does not appear to bear the nutritional information required by regulation.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
LACKS N/C
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/1/2023 | 54ECA84MILK THISTLE | Division of Southeast Imports (DSEI) | |
| 12/7/2022 | 54ECA84MILK THISTLE | Division of Southeast Imports (DSEI) | |
| 11/29/2022 | 54FCA84MILK THISTLE (HERBAL & BOTANICAL OTHER THAN TEAS) | Division of Southeast Imports (DSEI) | |
| 11/29/2022 | 54YCY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is JSHEALTH's FDA import refusal history?
JSHEALTH (FEI: 3019760048) has 4 FDA import refusal record(s) in our database, spanning from 11/29/2022 to 2/1/2023.
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. JSHEALTH's FEI number is 3019760048.
What types of violations has JSHEALTH received?
JSHEALTH 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 JSHEALTH come from?
All FDA import refusal data for JSHEALTH 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.