Lyppard Australia Limited
⚠️ Moderate Risk
FEI: 3005609113 • Kayaborough • AUSTRALIA
FEI Number
3005609113
Location
Kayaborough
Country
AUSTRALIAAddress
14 Firebalya Boulevard, , Kayaborough, , 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
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/26/2011 | 65CRN03POTASSIUM ASPARTATE AND MAGNESIUM ASPARTATE (NUTRIENT/TONIC) | 16DIRECTIONS | Seattle District Office (SEA-DO) |
| 9/26/2011 | 65BQZ99MUCOLYTIC N.E.C. | 16DIRECTIONS | Seattle District Office (SEA-DO) |
| 9/26/2011 | 60KQK99ANABOLIC, N.E.C. | 16DIRECTIONS | Seattle District Office (SEA-DO) |
| 10/20/2006 | 66VRK99MISCELLANEOUS PATENT MEDICINES, ETC. | 72NEW VET DR | New Orleans District Office (NOL-DO) |
| 10/20/2006 | 66VRK99MISCELLANEOUS PATENT MEDICINES, ETC. | 72NEW VET DR | New Orleans District Office (NOL-DO) |
| 10/20/2006 | 62GIN46KETOPROFEN (ANTI-INFLAMMATORY) | 72NEW VET DR | New Orleans District Office (NOL-DO) |
| 10/20/2006 | 62GIN46KETOPROFEN (ANTI-INFLAMMATORY) | 72NEW VET DR | New Orleans District Office (NOL-DO) |
| 10/20/2006 | 62GIN46KETOPROFEN (ANTI-INFLAMMATORY) | 72NEW VET DR | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Lyppard Australia Limited's FDA import refusal history?
Lyppard Australia Limited (FEI: 3005609113) has 8 FDA import refusal record(s) in our database, spanning from 10/20/2006 to 9/26/2011.
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. Lyppard Australia Limited's FEI number is 3005609113.
What types of violations has Lyppard Australia Limited received?
Lyppard Australia Limited 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 Lyppard Australia Limited come from?
All FDA import refusal data for Lyppard Australia Limited 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.