UNISON PHARMACUETICALS PVT LTD
⚠️ High Risk
FEI: 3023485223 • Ahmedabad • INDIA
FEI Number
3023485223
Location
Ahmedabad
Country
INDIAAddress
C6 Steel Town Opp Nova, , Ahmedabad, , 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/21/2025 | 60SDA27RABEPRAZOLE SODIUM (ANTACID) (ANTI-ULCER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/21/2025 | 62ODA12VALSARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/6/2024 | 63BDY30THEOPHYLLINE (BRONCHODILATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/6/2024 | 61EDY09MONTELUKAST SODIUM (ANTI-ASTHMATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/6/2024 | 61JDY16ROSUVASTATIN CALCIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/6/2024 | 62ODY09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/29/2024 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 3/29/2024 | 60LDY01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is UNISON PHARMACUETICALS PVT LTD's FDA import refusal history?
UNISON PHARMACUETICALS PVT LTD (FEI: 3023485223) has 8 FDA import refusal record(s) in our database, spanning from 3/29/2024 to 3/21/2025.
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. UNISON PHARMACUETICALS PVT LTD's FEI number is 3023485223.
What types of violations has UNISON PHARMACUETICALS PVT LTD received?
UNISON PHARMACUETICALS PVT LTD 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 UNISON PHARMACUETICALS PVT LTD come from?
All FDA import refusal data for UNISON PHARMACUETICALS PVT LTD 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.