Jubilant Pharmova Limited
⚠️ Moderate Risk
FEI: 3003144728 • Mysore, Karnataka • INDIA
FEI Number
3003144728
Location
Mysore, Karnataka
Country
INDIAAddress
No 18, 56, 57 & 58 Kiadb Industrial Area, Nanjangud, Mysore, Karnataka, 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
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/21/2018 | 66NCS07OXCARBAZEPINE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | Division of Northeast Imports (DNEI) | |
| 8/16/2018 | 62JCS13DONEPEZIL HCL (ANTI-PARKINSONIAN) | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 6/21/2017 | 62JIS13DONEPEZIL HCL (ANTI-PARKINSONIAN) | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 6/26/2006 | 56IIR76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Jubilant Pharmova Limited's FDA import refusal history?
Jubilant Pharmova Limited (FEI: 3003144728) has 4 FDA import refusal record(s) in our database, spanning from 6/26/2006 to 11/21/2018.
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. Jubilant Pharmova Limited's FEI number is 3003144728.
What types of violations has Jubilant Pharmova Limited received?
Jubilant Pharmova Limited 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 Jubilant Pharmova Limited come from?
All FDA import refusal data for Jubilant Pharmova 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.