HIKMA PHARMACEUTICALS USA INC
⚠️ High Risk
FEI: 3017452050 • Berkeley Heights, NJ • UNITED STATES
FEI Number
3017452050
Location
Berkeley Heights, NJ
Country
UNITED STATESAddress
200 Connell Dr Ste 4000, , Berkeley Heights, 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
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
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).
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 |
|---|---|---|---|
| 5/13/2025 | 60RCA18ORLISTAT/TETRAHYDROLIPSTATIN (ANOREXIC) | Division of Southeast Imports (DSEI) | |
| 2/12/2024 | 61KCK22GLYCOPYRROLATE (ANTI-CHOLINERGIC) | 179AGR RX | Division of Northeast Imports (DNEI) |
| 2/12/2024 | 60CCK09PHENYLEPHRINE HCL (ADRENERGIC) | 179AGR RX | Division of Northeast Imports (DNEI) |
| 4/12/2021 | 64LCA50PREDNISOLONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is HIKMA PHARMACEUTICALS USA INC's FDA import refusal history?
HIKMA PHARMACEUTICALS USA INC (FEI: 3017452050) has 4 FDA import refusal record(s) in our database, spanning from 4/12/2021 to 5/13/2025.
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. HIKMA PHARMACEUTICALS USA INC's FEI number is 3017452050.
What types of violations has HIKMA PHARMACEUTICALS USA INC received?
HIKMA PHARMACEUTICALS USA INC 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 HIKMA PHARMACEUTICALS USA INC come from?
All FDA import refusal data for HIKMA 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.