TTK Healthcare Limited
⚠️ High Risk
FEI: 3003244915 • Chennai, Tamil Nadu • INDIA
FEI Number
3003244915
Location
Chennai, Tamil Nadu
Country
INDIAAddress
5 Old Trunk Road, , Chennai, Tamil Nadu, India
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
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).
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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 |
|---|---|---|---|
| 12/5/2024 | 85HISCONDOM | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 9/15/2006 | 60SML99ANTACID, N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 8/30/2006 | 60SBL99ANTACID, N.E.C. | San Francisco District Office (SAN-DO) | |
| 5/27/2005 | 66VCL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is TTK Healthcare Limited's FDA import refusal history?
TTK Healthcare Limited (FEI: 3003244915) has 4 FDA import refusal record(s) in our database, spanning from 5/27/2005 to 12/5/2024.
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. TTK Healthcare Limited's FEI number is 3003244915.
What types of violations has TTK Healthcare Limited received?
TTK Healthcare Limited has been cited for 4 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 TTK Healthcare Limited come from?
All FDA import refusal data for TTK Healthcare 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.