Shiva Products
⚠️ Moderate Risk
FEI: 3008822460 • Khairpada, Maharashtra • INDIA
FEI Number
3008822460
Location
Khairpada, Maharashtra
Country
INDIAAddress
B/18 Dwarka Indl Estate, Waliv, Khairpada, 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
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).
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/15/2016 | 76DYHADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 6/15/2016 | 76DYHADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 6/15/2016 | 76DYHADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 10/1/2015 | 76EIDSYRINGE, RESTORATIVE AND IMPRESSION MATERIAL | Division of Southeast Imports (DSEI) | |
| 8/3/2012 | 80FMFSYRINGE, PISTON | 341REGISTERED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Shiva Products's FDA import refusal history?
Shiva Products (FEI: 3008822460) has 5 FDA import refusal record(s) in our database, spanning from 8/3/2012 to 6/15/2016.
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. Shiva Products's FEI number is 3008822460.
What types of violations has Shiva Products received?
Shiva Products 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 Shiva Products come from?
All FDA import refusal data for Shiva Products 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.