Amneal Pharmaceuticals, LLC
⚠️ Moderate Risk
FEI: 3012625281 • Bridgewater, NJ • UNITED STATES
FEI Number
3012625281
Location
Bridgewater, NJ
Country
UNITED STATESAddress
400 Crossing Blvd Fl 3, , Bridgewater, NJ, United States
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
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/12/2024 | 64LCK61TRIAMCINOLONE ACETONIDE (GLUCOCORTICOID) | 179AGR RX | Division of Northeast Imports (DNEI) |
| 1/10/2022 | 66FDA99SUPPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/8/2020 | 64BDY37SPIRONOLACTONE (DIURETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/9/2018 | 61PDY26METFORMIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/13/2012 | 64RBB99HORMONE N.E.C. | 179AGR RX | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Amneal Pharmaceuticals, LLC's FDA import refusal history?
Amneal Pharmaceuticals, LLC (FEI: 3012625281) has 5 FDA import refusal record(s) in our database, spanning from 7/13/2012 to 2/12/2024.
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. Amneal Pharmaceuticals, LLC's FEI number is 3012625281.
What types of violations has Amneal Pharmaceuticals, LLC received?
Amneal Pharmaceuticals, LLC has been cited for 2 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 Amneal Pharmaceuticals, LLC come from?
All FDA import refusal data for Amneal Pharmaceuticals, LLC 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.