DMS Holdings, Inc. dba HealthSmart
⚠️ Moderate Risk
FEI: 1000143485 • Waukegan, IL • UNITED STATES
FEI Number
1000143485
Location
Waukegan, IL
Country
UNITED STATESAddress
1931 Norman Dr, , Waukegan, 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).
DE/RX KIT
The article appears to be a combination medical device/prescription drug kit for which the prescription drug component was manufactured in the U.S., is 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.
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.
POSS N/STR
The article appears to consist in whole or in part of any filthy, putrid, or decomposed substance, namely, potentially infectious organisms
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.
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 |
|---|---|---|---|
| 8/4/2008 | 74DXQCUFF, BLOOD-PRESSURE | Chicago District Office (CHI-DO) | |
| 8/4/2008 | 74LDESTETHOSCOPE, MANUAL | 118NOT LISTED | Chicago District Office (CHI-DO) |
| 5/23/2008 | 74LDESTETHOSCOPE, MANUAL | Chicago District Office (CHI-DO) | |
| 5/23/2008 | 74DXQCUFF, BLOOD-PRESSURE | Chicago District Office (CHI-DO) | |
| 2/5/2008 | 80KYZSYRINGE, IRRIGATING | New York District Office (NYK-DO) |
Frequently Asked Questions
What is DMS Holdings, Inc. dba HealthSmart's FDA import refusal history?
DMS Holdings, Inc. dba HealthSmart (FEI: 1000143485) has 5 FDA import refusal record(s) in our database, spanning from 2/5/2008 to 8/4/2008.
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. DMS Holdings, Inc. dba HealthSmart's FEI number is 1000143485.
What types of violations has DMS Holdings, Inc. dba HealthSmart received?
DMS Holdings, Inc. dba HealthSmart 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 DMS Holdings, Inc. dba HealthSmart come from?
All FDA import refusal data for DMS Holdings, Inc. dba HealthSmart 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.