ASHISH LIFE SCIENCE PVT LIMITED
⚠️ High Risk
FEI: 3015779744 • Mumbai, Maharashtra • INDIA
FEI Number
3015779744
Location
Mumbai, Maharashtra
Country
INDIAAddress
1101 Ashiyana Building, Shri Balasaheb Devras Marg, Mumbai, Maharashtra, India
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
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
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 |
|---|---|---|---|
| 10/12/2023 | 60ZDY15IVERMECTIN AND COMBINATIONS (ANTIPARASITIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/12/2023 | 60ZDY12FENBENDAZOLE (ANTIPARASITIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/24/2019 | 62KPY10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 72NEW VET DR | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is ASHISH LIFE SCIENCE PVT LIMITED's FDA import refusal history?
ASHISH LIFE SCIENCE PVT LIMITED (FEI: 3015779744) has 3 FDA import refusal record(s) in our database, spanning from 10/24/2019 to 10/12/2023.
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. ASHISH LIFE SCIENCE PVT LIMITED's FEI number is 3015779744.
What types of violations has ASHISH LIFE SCIENCE PVT LIMITED received?
ASHISH LIFE SCIENCE PVT 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 ASHISH LIFE SCIENCE PVT LIMITED come from?
All FDA import refusal data for ASHISH LIFE SCIENCE PVT 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.