Marley Biotechnology Inc.
⚠️ High Risk
FEI: 3030265771 • Pittsford, NY • UNITED STATES
FEI Number
3030265771
Location
Pittsford, NY
Country
UNITED STATESAddress
115 Sullys Trl Ste 14, , Pittsford, NY, United States
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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
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 |
|---|---|---|---|
| 11/13/2024 | 66VDK99MISCELLANEOUS PATENT MEDICINES, ETC. | 72NEW VET DR | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Marley Biotechnology Inc.'s FDA import refusal history?
Marley Biotechnology Inc. (FEI: 3030265771) has 1 FDA import refusal record(s) in our database, spanning from 11/13/2024 to 11/13/2024.
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. Marley Biotechnology Inc.'s FEI number is 3030265771.
What types of violations has Marley Biotechnology Inc. received?
Marley Biotechnology Inc. has been cited for 1 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 Marley Biotechnology Inc. come from?
All FDA import refusal data for Marley Biotechnology Inc. 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.