Medline Industries, LP
⚠️ High Risk
FEI: 1417592 • Northfield, IL • UNITED STATES
FEI Number
1417592
Location
Northfield, IL
Country
UNITED STATESAddress
3 Lakes Dr, , Northfield, IL, 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
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.
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).
INSANITARY
The article is subject to refusal of admission pursuant to section 801(a)(3) in that the article appears to have been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
HOLES
The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
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.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/13/2025 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of Northern Border Imports (DNBI) | |
| 2/13/2025 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of Northern Border Imports (DNBI) | |
| 5/8/2023 | 56YBJ99ANTIBIOTIC N.E.C. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 7/21/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 483DRUG NAME | Division of Northeast Imports (DNEI) |
| 3/6/2014 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | New England District Office (NWE-DO) | |
| 3/6/2014 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | New England District Office (NWE-DO) | |
| 3/6/2014 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | New England District Office (NWE-DO) | |
| 3/6/2014 | 74LLKLEGGING, COMPRESSION, NON-INFLATABLE | New England District Office (NWE-DO) | |
| 8/3/2006 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 508NO 510(K) | Southwest Import District Office (SWI-DO) |
| 8/3/2006 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 508NO 510(K) | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Medline Industries, LP's FDA import refusal history?
Medline Industries, LP (FEI: 1417592) has 10 FDA import refusal record(s) in our database, spanning from 8/3/2006 to 2/13/2025.
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. Medline Industries, LP's FEI number is 1417592.
What types of violations has Medline Industries, LP received?
Medline Industries, LP has been cited for 6 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 Medline Industries, LP come from?
All FDA import refusal data for Medline Industries, LP 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.