APP PHARMACEUTICALS
⚠️ Moderate Risk
FEI: 3030271452 • Lake Zurich, IL • UNITED STATES
FEI Number
3030271452
Location
Lake Zurich, IL
Country
UNITED STATESAddress
3 Corporate Dr, , Lake Zurich, IL, 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
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 | 60QCK40LIDOCAINE HCL (ANESTHETIC) | 179AGR RX | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is APP PHARMACEUTICALS's FDA import refusal history?
APP PHARMACEUTICALS (FEI: 3030271452) has 1 FDA import refusal record(s) in our database, spanning from 2/12/2024 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. APP PHARMACEUTICALS's FEI number is 3030271452.
What types of violations has APP PHARMACEUTICALS received?
APP PHARMACEUTICALS 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 APP PHARMACEUTICALS come from?
All FDA import refusal data for APP PHARMACEUTICALS 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.