Zydus Pharmaceuticals (USA) Inc
⚠️ High Risk
FEI: 3008444937 • Pennington, NJ • UNITED STATES
FEI Number
3008444937
Location
Pennington, NJ
Country
UNITED STATESAddress
73 Route 31 N, , Pennington, NJ, United States
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 |
|---|---|---|---|
| 10/14/2025 | 61NCY80VENLAFAXINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/1/2022 | 65PDY03TAMSULOSIN HCL (REGULATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/3/2021 | 62OCY41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/17/2019 | 65RDB14POTASSIUM CHLORIDE (REPLENISHER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/17/2019 | 62ODB41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/7/2017 | 61NCA76PAROXETINE (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Zydus Pharmaceuticals (USA) Inc's FDA import refusal history?
Zydus Pharmaceuticals (USA) Inc (FEI: 3008444937) has 6 FDA import refusal record(s) in our database, spanning from 6/7/2017 to 10/14/2025.
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. Zydus Pharmaceuticals (USA) Inc's FEI number is 3008444937.
What types of violations has Zydus Pharmaceuticals (USA) Inc received?
Zydus Pharmaceuticals (USA) Inc 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 Zydus Pharmaceuticals (USA) Inc come from?
All FDA import refusal data for Zydus Pharmaceuticals (USA) Inc 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.