Lucas Papaw Remedies
⚠️ Moderate Risk
FEI: 3011009505 • Acacia Ridgeacacia Ridge • AUSTRALIA
FEI Number
3011009505
Location
Acacia Ridgeacacia Ridge
Country
AUSTRALIAAddress
15 Durbell Street, , Acacia Ridgeacacia Ridge, , 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
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/18/2019 | 64DBJ99EMOLLIENT, LUBRICANT, N.E.C. | 72NEW VET DR | Division of Northern Border Imports (DNBI) |
| 9/17/2014 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 9/17/2014 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 9/17/2014 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Lucas Papaw Remedies's FDA import refusal history?
Lucas Papaw Remedies (FEI: 3011009505) has 4 FDA import refusal record(s) in our database, spanning from 9/17/2014 to 4/18/2019.
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. Lucas Papaw Remedies's FEI number is 3011009505.
What types of violations has Lucas Papaw Remedies received?
Lucas Papaw Remedies has been cited for 3 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 Lucas Papaw Remedies come from?
All FDA import refusal data for Lucas Papaw Remedies 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.