TTK HEALTHCARE LIMITED - PROTECTIVE DEVICES DIVISION
⚠️ Moderate Risk
FEI: 3005203207 • Virudhunager, Tamil Nadu • INDIA
FEI Number
3005203207
Location
Virudhunager, Tamil Nadu
Country
INDIAAddress
20 Perali Road, NO. 20, 21, PERALI ROAD, Virudhunager, Tamil Nadu, 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
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 |
|---|---|---|---|
| 5/28/2025 | 85HISCONDOM | 508NO 510(K) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is TTK HEALTHCARE LIMITED - PROTECTIVE DEVICES DIVISION's FDA import refusal history?
TTK HEALTHCARE LIMITED - PROTECTIVE DEVICES DIVISION (FEI: 3005203207) has 1 FDA import refusal record(s) in our database, spanning from 5/28/2025 to 5/28/2025.
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. TTK HEALTHCARE LIMITED - PROTECTIVE DEVICES DIVISION's FEI number is 3005203207.
What types of violations has TTK HEALTHCARE LIMITED - PROTECTIVE DEVICES DIVISION received?
TTK HEALTHCARE LIMITED - PROTECTIVE DEVICES DIVISION has been cited for 1 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 - PROTECTIVE DEVICES DIVISION come from?
All FDA import refusal data for TTK HEALTHCARE LIMITED - PROTECTIVE DEVICES DIVISION 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.