Swisse Vitamines Syd
✅ Low Risk
FEI: 3009711015 • Alexandria, New South Wales • AUSTRALIA
FEI Number
3009711015
Location
Alexandria, New South Wales
Country
AUSTRALIAAddress
Unitperryparkestate 3, 33 Maddox St, Alexandria, New South Wales, Australia
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity 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
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).
SBGINSENG
The article is subject to refusal of admission in that it appears to be Misbranded because it or its ingredients purport to be or are represented as Ginseng, but are not an herb or herbal ingredient derived from a plant classified within the genus Panax.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/21/2013 | 54YCL04GINSENG UNCONVENTIONAL DIETARY SPECIALITY FOR HUMANS OR ANIMALS | 3140SBGINSENG | Cincinnati District Office (CIN-DO) |
| 3/21/2013 | 54YCL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Swisse Vitamines Syd's FDA import refusal history?
Swisse Vitamines Syd (FEI: 3009711015) has 2 FDA import refusal record(s) in our database, spanning from 3/21/2013 to 3/21/2013.
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. Swisse Vitamines Syd's FEI number is 3009711015.
What types of violations has Swisse Vitamines Syd received?
Swisse Vitamines Syd 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 Swisse Vitamines Syd come from?
All FDA import refusal data for Swisse Vitamines Syd 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.