Baxter Healthcare
⚠️ Moderate Risk
FEI: 3010821082 • Engleweek, CO • UNITED STATES
FEI Number
3010821082
Location
Engleweek, CO
Country
UNITED STATESAddress
4445 Grasslands Dr, , Engleweek, CO, 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 |
|---|---|---|---|
| 3/22/2023 | 65RDK19SODIUM CHLORIDE (REPLENISHER) | 179AGR RX | Division of West Coast Imports (DWCI) |
| 3/22/2023 | 65RDK19SODIUM CHLORIDE (REPLENISHER) | 179AGR RX | Division of West Coast Imports (DWCI) |
| 3/22/2023 | 65RDK19SODIUM CHLORIDE (REPLENISHER) | 179AGR RX | Division of West Coast Imports (DWCI) |
| 3/22/2023 | 61LDH06DIPHENADIONE (ANTI-COAGULANT) | 179AGR RX | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Baxter Healthcare's FDA import refusal history?
Baxter Healthcare (FEI: 3010821082) has 4 FDA import refusal record(s) in our database, spanning from 3/22/2023 to 3/22/2023.
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. Baxter Healthcare's FEI number is 3010821082.
What types of violations has Baxter Healthcare received?
Baxter Healthcare 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 Baxter Healthcare come from?
All FDA import refusal data for Baxter Healthcare 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.