Baxter Healthcare Corporation
⚠️ Moderate Risk
FEI: 1416980 • Round Lake, IL • UNITED STATES
FEI Number
1416980
Location
Round Lake, IL
Country
UNITED STATESAddress
25212 W Il Route 120, , Round Lake, 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
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).
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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/24/2012 | 80FRNPUMP, INFUSION | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 2/24/2006 | 56JCK31CLINDAMYCIN PHOSPHATE (LINCOMYCINS) | New York District Office (NYK-DO) | |
| 2/24/2006 | 56JCK31CLINDAMYCIN PHOSPHATE (LINCOMYCINS) | New York District Office (NYK-DO) | |
| 2/24/2006 | 56JCK31CLINDAMYCIN PHOSPHATE (LINCOMYCINS) | New York District Office (NYK-DO) | |
| 2/24/2006 | 56JCK31CLINDAMYCIN PHOSPHATE (LINCOMYCINS) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Baxter Healthcare Corporation's FDA import refusal history?
Baxter Healthcare Corporation (FEI: 1416980) has 5 FDA import refusal record(s) in our database, spanning from 2/24/2006 to 1/24/2012.
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 Corporation's FEI number is 1416980.
What types of violations has Baxter Healthcare Corporation received?
Baxter Healthcare Corporation has been cited for 3 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 Corporation come from?
All FDA import refusal data for Baxter Healthcare Corporation 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.