Kareshima Dentals PVT. LTD
✅ Low Risk
FEI: 3006619805 • Mumbai, Maharashtra • INDIA
FEI Number
3006619805
Location
Mumbai, Maharashtra
Country
INDIAAddress
52 S K Ahire Marg, , Mumbai, Maharashtra, India
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity 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
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).
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
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).
Refusal History
Frequently Asked Questions
What is Kareshima Dentals PVT. LTD's FDA import refusal history?
Kareshima Dentals PVT. LTD (FEI: 3006619805) has 1 FDA import refusal record(s) in our database, spanning from 4/29/2008 to 4/29/2008.
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. Kareshima Dentals PVT. LTD's FEI number is 3006619805.
What types of violations has Kareshima Dentals PVT. LTD received?
Kareshima Dentals PVT. LTD has been cited for 3 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 Kareshima Dentals PVT. LTD come from?
All FDA import refusal data for Kareshima Dentals PVT. LTD 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.