M/S. SALVI CHEMICAL INDUSTRIES LTD
⚠️ Moderate Risk
FEI: 3019089728 • Mumbai • INDIA
FEI Number
3019089728
Location
Mumbai
Country
INDIAAddress
A Wing 107/108, Western Edge 2, Near Metro Mall, Mumbai, , 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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
DR PACKGNG
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to be a drug and its container is so made, formed, or filled as to be misleading
Refusal History
Frequently Asked Questions
What is M/S. SALVI CHEMICAL INDUSTRIES LTD's FDA import refusal history?
M/S. SALVI CHEMICAL INDUSTRIES LTD (FEI: 3019089728) has 1 FDA import refusal record(s) in our database, spanning from 2/7/2023 to 2/7/2023.
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. M/S. SALVI CHEMICAL INDUSTRIES LTD's FEI number is 3019089728.
What types of violations has M/S. SALVI CHEMICAL INDUSTRIES LTD received?
M/S. SALVI CHEMICAL INDUSTRIES 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 M/S. SALVI CHEMICAL INDUSTRIES LTD come from?
All FDA import refusal data for M/S. SALVI CHEMICAL INDUSTRIES 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.