Baxter Healthcare Corp
⚠️ High Risk
FEI: 2937398 • Hayward, CA • UNITED STATES
FEI Number
2937398
Location
Hayward, CA
Country
UNITED STATESAddress
21026 Alexander Ct, , Hayward, CA, United States
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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.
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/15/2024 | 65RDK19SODIUM CHLORIDE (REPLENISHER) | 179AGR RX | Division of Northern Border Imports (DNBI) |
| 11/15/2024 | 65RDK19SODIUM CHLORIDE (REPLENISHER) | Division of Northern Border Imports (DNBI) | |
| 11/12/2024 | 65RDK19SODIUM CHLORIDE (REPLENISHER) | 179AGR RX | Division of Northern Border Imports (DNBI) |
| 11/12/2024 | 65RDK19SODIUM CHLORIDE (REPLENISHER) | 179AGR RX | Division of Northern Border Imports (DNBI) |
| 11/12/2024 | 65RDK19SODIUM CHLORIDE (REPLENISHER) | 179AGR RX | Division of Northern Border Imports (DNBI) |
| 11/12/2024 | 65RDK19SODIUM CHLORIDE (REPLENISHER) | 179AGR RX | Division of Northern Border Imports (DNBI) |
| 11/12/2024 | 65RDK19SODIUM CHLORIDE (REPLENISHER) | 179AGR RX | Division of Northern Border Imports (DNBI) |
| 11/12/2024 | 65RDK19SODIUM CHLORIDE (REPLENISHER) | 179AGR RX | Division of Northern Border Imports (DNBI) |
| 11/12/2024 | 65RDK19SODIUM CHLORIDE (REPLENISHER) | 179AGR RX | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Baxter Healthcare Corp's FDA import refusal history?
Baxter Healthcare Corp (FEI: 2937398) has 9 FDA import refusal record(s) in our database, spanning from 11/12/2024 to 11/15/2024.
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. Baxter Healthcare Corp's FEI number is 2937398.
What types of violations has Baxter Healthcare Corp received?
Baxter Healthcare Corp has been cited for 4 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 Corp come from?
All FDA import refusal data for Baxter Healthcare Corp 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.