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Amneal Pharmaceuticals of New York, LLC

⚠️ Moderate Risk

FEI: 2434153 • Hauppauge, NY • UNITED STATES

FEI

FEI Number

2434153

📍

Location

Hauppauge, NY

🇺🇸
🏢

Address

75 Adams Ave, , Hauppauge, NY, United States

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

1
Total Refusals
1
Unique Violations
4/15/2019
Latest Refusal
4/15/2019
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

751×

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

DateProductViolationsDivision
4/15/2019
62LCK44ATOVAQUONE (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Amneal Pharmaceuticals of New York, LLC's FDA import refusal history?

Amneal Pharmaceuticals of New York, LLC (FEI: 2434153) has 1 FDA import refusal record(s) in our database, spanning from 4/15/2019 to 4/15/2019.

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 of New York, LLC's FEI number is 2434153.

What types of violations has Amneal Pharmaceuticals of New York, LLC received?

Amneal Pharmaceuticals of New York, LLC 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 Amneal Pharmaceuticals of New York, LLC come from?

All FDA import refusal data for Amneal Pharmaceuticals of New York, 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.