Kusuri Products Limited
⚠️ Moderate Risk
FEI: 3010886312 • Newton Abbot, Devon • UNITED KINGDOM
FEI Number
3010886312
Location
Newton Abbot, Devon
Country
UNITED KINGDOMAddress
Unit 12, Wentworth Road, Heathfield Industrial Estate, Newton Abbot, Devon, United Kingdom
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.
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/24/2023 | 62LBY02FLUBENDAZOLE (ANTI-PROTOZOAL, ANTI-LEISHMANIAL, ANTI-MALARIAL) | Division of Southeast Imports (DSEI) | |
| 10/25/2019 | 62FPL99ANTI-INFECTIVE, TOPICAL N.E.C. | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 10/25/2019 | 55QP41BENZALKONIUM CHLORIDE (PHARMACEUTIC NECESSITY - PRESERVATIVE) | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 10/25/2019 | 62FPL20IODINE (ANTI-INFECTIVE, TOPICAL) | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 10/25/2019 | 64DOZ99EMOLLIENT, LUBRICANT, N.E.C. | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 10/25/2019 | 62LPK02FLUBENDAZOLE (ANTI-PROTOZOAL, ANTI-LEISHMANIAL, ANTI-MALARIAL) | 72NEW VET DR | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Kusuri Products Limited's FDA import refusal history?
Kusuri Products Limited (FEI: 3010886312) has 6 FDA import refusal record(s) in our database, spanning from 10/25/2019 to 10/24/2023.
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. Kusuri Products Limited's FEI number is 3010886312.
What types of violations has Kusuri Products Limited received?
Kusuri Products 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 Kusuri Products Limited come from?
All FDA import refusal data for Kusuri Products 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.