Baxter Healthcare S.A.
⚠️ Moderate Risk
FEI: 3002806443 • Haina • DOMINICAN REPUBLIC
FEI Number
3002806443
Location
Haina
Country
DOMINICAN REPUBLICAddress
Parque Industrial Itabo, Carretera Sanchez Km 18. 5, Haina, , Dominican Republic
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
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/8/2021 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 12/27/2019 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 12/27/2019 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 12/27/2019 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 12/27/2019 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 12/27/2019 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 12/20/2018 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 12/20/2018 | 80FMGSTOPCOCK, I.V. SET | 508NO 510(K) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Baxter Healthcare S.A.'s FDA import refusal history?
Baxter Healthcare S.A. (FEI: 3002806443) has 8 FDA import refusal record(s) in our database, spanning from 12/20/2018 to 12/8/2021.
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.A.'s FEI number is 3002806443.
What types of violations has Baxter Healthcare S.A. received?
Baxter Healthcare S.A. 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 Baxter Healthcare S.A. come from?
All FDA import refusal data for Baxter Healthcare S.A. 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.