Suru International Pvt Ltd.
⚠️ Moderate Risk
FEI: 3006044050 • Maharashtra • INDIA
FEI Number
3006044050
Location
Maharashtra
Country
INDIAAddress
11 Sona Udyog Andheri, , Maharashtra, , 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
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).
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
Frequently Asked Questions
What is Suru International Pvt Ltd.'s FDA import refusal history?
Suru International Pvt Ltd. (FEI: 3006044050) has 2 FDA import refusal record(s) in our database, spanning from 12/28/2006 to 12/28/2006.
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. Suru International Pvt Ltd.'s FEI number is 3006044050.
What types of violations has Suru International Pvt Ltd. received?
Suru International Pvt Ltd. 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 Suru International Pvt Ltd. come from?
All FDA import refusal data for Suru International 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.