HEALTHIUM MEDTECH LIMITED
⚠️ Moderate Risk
FEI: 3004944585 • Bangalore, Karnataka • INDIA
FEI Number
3004944585
Location
Bangalore, Karnataka
Country
INDIAAddress
472 D 13th Cross, 4TH PHASE, PEENYA INDUSTRIAL AREA, Bangalore, Karnataka, 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
DEVICE GMP
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
DE IMP GMP
The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities or controls used for, the manufacture of the device do not conform to the applicable requirements of section 520(f).
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).
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/26/2013 | 79GAKSUTURE, ABSORBABLE | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 7/26/2013 | 79GAOSUTURE, NONABSORBABLE | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 3/6/2013 | 79KGOSURGEON'S GLOVES | Cincinnati District Office (CIN-DO) | |
| 10/2/2012 | 79FTMMESH, SURGICAL | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 9/10/2012 | 79FTMMESH, SURGICAL | 2780DEVICEGMPS | Florida District Office (FLA-DO) |
| 7/6/2012 | 79GAMSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID | 2780DEVICEGMPS | New Orleans District Office (NOL-DO) |
| 12/13/2011 | 79FTMMESH, SURGICAL | 2780DEVICEGMPS | Florida District Office (FLA-DO) |
| 12/13/2011 | 79FTMMESH, SURGICAL | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 10/5/2011 | 79GAOSUTURE, NONABSORBABLE | 226DEVICE GMP | Florida District Office (FLA-DO) |
| 10/5/2011 | 79GAOSUTURE, NONABSORBABLE | 226DEVICE GMP | Florida District Office (FLA-DO) |
| 10/5/2011 | 79GAKSUTURE, ABSORBABLE | 226DEVICE GMP | Florida District Office (FLA-DO) |
| 10/5/2011 | 79GAOSUTURE, NONABSORBABLE | 226DEVICE GMP | Florida District Office (FLA-DO) |
| 10/5/2011 | 79GAKSUTURE, ABSORBABLE | 226DEVICE GMP | Florida District Office (FLA-DO) |
| 10/5/2011 | 79GAOSUTURE, NONABSORBABLE | 226DEVICE GMP | Florida District Office (FLA-DO) |
| 10/5/2011 | 79GAOSUTURE, NONABSORBABLE | 226DEVICE GMP | Florida District Office (FLA-DO) |
| 10/5/2011 | 79GAKSUTURE, ABSORBABLE | 226DEVICE GMP | Florida District Office (FLA-DO) |
| 10/5/2011 | 79GAOSUTURE, NONABSORBABLE | 226DEVICE GMP | Florida District Office (FLA-DO) |
| 10/5/2011 | 79GAKSUTURE, ABSORBABLE | 226DEVICE GMP | Florida District Office (FLA-DO) |
| 12/18/2008 | 79GAMSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID | 341REGISTERED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is HEALTHIUM MEDTECH LIMITED's FDA import refusal history?
HEALTHIUM MEDTECH LIMITED (FEI: 3004944585) has 19 FDA import refusal record(s) in our database, spanning from 12/18/2008 to 7/26/2013.
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. HEALTHIUM MEDTECH LIMITED's FEI number is 3004944585.
What types of violations has HEALTHIUM MEDTECH LIMITED received?
HEALTHIUM MEDTECH LIMITED 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 HEALTHIUM MEDTECH LIMITED come from?
All FDA import refusal data for HEALTHIUM MEDTECH LIMITED 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.