Welch Allyn Inc (Baxter affiliate)
⚠️ High Risk
FEI: 2183461 • Milwaukee, WI • UNITED STATES
FEI Number
2183461
Location
Milwaukee, WI
Country
UNITED STATESAddress
7865 N 86th St, , Milwaukee, WI, 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
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).
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).
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.
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.
DV QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/6/2025 | 74DPSELECTROCARDIOGRAPH | Division of Northern Border Imports (DNBI) | |
| 9/24/2024 | 74DPSELECTROCARDIOGRAPH | Division of Southeast Imports (DSEI) | |
| 2/9/2021 | 74DPSELECTROCARDIOGRAPH | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 10/22/2020 | 74DRXELECTRODE, ELECTROCARDIOGRAPH | 3280FRNMFGREG | Division of Northeast Imports (DNEI) |
| 9/23/2020 | 74DPSELECTROCARDIOGRAPH | Division of Northern Border Imports (DNBI) | |
| 5/29/2020 | 74DPSELECTROCARDIOGRAPH | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/25/2020 | 74DPSELECTROCARDIOGRAPH | Division of Southeast Imports (DSEI) | |
| 3/23/2020 | 74MHXMONITOR, PHYSIOLOGICAL, PATIENT | Division of West Coast Imports (DWCI) | |
| 1/21/2020 | 74DPSELECTROCARDIOGRAPH | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/27/2019 | 74DPSELECTROCARDIOGRAPH | Division of Southeast Imports (DSEI) | |
| 9/3/2019 | 74DPSELECTROCARDIOGRAPH | Division of West Coast Imports (DWCI) | |
| 5/31/2019 | 74DPSELECTROCARDIOGRAPH | Division of Northern Border Imports (DNBI) | |
| 9/8/2017 | 74DPSELECTROCARDIOGRAPH | Division of Southeast Imports (DSEI) | |
| 6/27/2017 | 74DPSELECTROCARDIOGRAPH | 341REGISTERED | Division of Northern Border Imports (DNBI) |
| 6/27/2017 | 74DPSELECTROCARDIOGRAPH | 341REGISTERED | Division of Northern Border Imports (DNBI) |
| 8/19/2015 | 74DPSELECTROCARDIOGRAPH | 118NOT LISTED | Philadelphia District Office (PHI-DO) |
| 10/22/2013 | 74DSHRECORDER, MAGNETIC TAPE, MEDICAL | 341REGISTERED | Florida District Office (FLA-DO) |
| 10/22/2013 | 74DSHRECORDER, MAGNETIC TAPE, MEDICAL | 341REGISTERED | Florida District Office (FLA-DO) |
| 4/17/2012 | 74DPSELECTROCARDIOGRAPH | 341REGISTERED | New York District Office (NYK-DO) |
| 11/19/2004 | 74DPSELECTROCARDIOGRAPH | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/31/2004 | 74LOSSYSTEM, ECG ANALYSIS, | 508NO 510(K) | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Welch Allyn Inc (Baxter affiliate)'s FDA import refusal history?
Welch Allyn Inc (Baxter affiliate) (FEI: 2183461) has 21 FDA import refusal record(s) in our database, spanning from 8/31/2004 to 3/6/2025.
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. Welch Allyn Inc (Baxter affiliate)'s FEI number is 2183461.
What types of violations has Welch Allyn Inc (Baxter affiliate) received?
Welch Allyn Inc (Baxter affiliate) has been cited for 5 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 Welch Allyn Inc (Baxter affiliate) come from?
All FDA import refusal data for Welch Allyn Inc (Baxter affiliate) 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.