EAST WEST PHARMA INDIA PRIVATE L
⚠️ Moderate Risk
FEI: 3022313560 • Haridwar • INDIA
FEI Number
3022313560
Location
Haridwar
Country
INDIAAddress
Kh No 196 Raipur Indust, , Haridwar, , India
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/11/2024 | 61NCA29FLUOXETINE (ANTI-DEPRESSANT) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is EAST WEST PHARMA INDIA PRIVATE L's FDA import refusal history?
EAST WEST PHARMA INDIA PRIVATE L (FEI: 3022313560) has 1 FDA import refusal record(s) in our database, spanning from 4/11/2024 to 4/11/2024.
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. EAST WEST PHARMA INDIA PRIVATE L's FEI number is 3022313560.
What types of violations has EAST WEST PHARMA INDIA PRIVATE L received?
EAST WEST PHARMA INDIA PRIVATE L 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 EAST WEST PHARMA INDIA PRIVATE L come from?
All FDA import refusal data for EAST WEST PHARMA INDIA PRIVATE L 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.