Hospira, Inc.
⚠️ Moderate Risk
FEI: 3004591926 • Lake Forest, IL • UNITED STATES
FEI Number
3004591926
Location
Lake Forest, IL
Country
UNITED STATESAddress
375 N Field Dr, , Lake Forest, 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.
DE/RX KIT
The article appears to be a combination medical device/prescription drug kit for which the prescription drug component was manufactured in the U.S., is 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 | 60QCK79BUPIVACAINE HYDROCHLORIDE (ANESTHETIC) | 179AGR RX | Division of Northeast Imports (DNEI) |
| 2/12/2024 | 60QCK79BUPIVACAINE HYDROCHLORIDE (ANESTHETIC) | 179AGR RX | Division of Northeast Imports (DNEI) |
| 2/12/2024 | 60QDK40LIDOCAINE HCL (ANESTHETIC) | 179AGR RX | Division of Northeast Imports (DNEI) |
| 9/10/2018 | 60QCP07LIDOCAINE | 3340DE/RX KIT | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Hospira, Inc.'s FDA import refusal history?
Hospira, Inc. (FEI: 3004591926) has 4 FDA import refusal record(s) in our database, spanning from 9/10/2018 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. Hospira, Inc.'s FEI number is 3004591926.
What types of violations has Hospira, Inc. received?
Hospira, Inc. 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 Hospira, Inc. come from?
All FDA import refusal data for Hospira, 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.