Hms Medical Systems
⚠️ Moderate Risk
FEI: 3010995485 • Chennai • INDIA
FEI Number
3010995485
Location
Chennai
Country
INDIAAddress
No 9 First Cross St, , Chennai, , India
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/17/2023 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Division of Southeast Imports (DSEI) | |
| 12/27/2017 | 89NHNLAMP, NON-HEATING, FOR ADJUNCTIVE USE IN PAIN THERAPY | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 12/27/2017 | 89KNMDEVICE, PRESSURE APPLYING | 118NOT LISTED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Hms Medical Systems's FDA import refusal history?
Hms Medical Systems (FEI: 3010995485) has 3 FDA import refusal record(s) in our database, spanning from 12/27/2017 to 11/17/2023.
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. Hms Medical Systems's FEI number is 3010995485.
What types of violations has Hms Medical Systems received?
Hms Medical Systems 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 Hms Medical Systems come from?
All FDA import refusal data for Hms Medical Systems 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.