Karnataka Soaps & Detergents Ltd
⚠️ Moderate Risk
FEI: 1000335673 • Bangalore • INDIA
FEI Number
1000335673
Location
Bangalore
Country
INDIAAddress
Chandrkrupa Crescent Rd, , Bangalore, , 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).
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
N-RX INACT
The article appears to be a nonprescription drug and fails to bear the established name of each inactive ingredient in alphabetical order on the outside container of the retail package.
COSMETFPLA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain an undeclared color additive which renders it misbranded within the meaning of Sections 1454(c)(3)(B) and 1456 of the Fair Packaging and Labeling Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/4/2020 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | Division of Northeast Imports (DNEI) | |
| 4/20/2018 | 53JI01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 197COSM COLOR | Division of Northern Border Imports (DNBI) |
| 3/8/2011 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | Southwest Import District Office (SWI-DO) | |
| 3/8/2011 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Karnataka Soaps & Detergents Ltd's FDA import refusal history?
Karnataka Soaps & Detergents Ltd (FEI: 1000335673) has 4 FDA import refusal record(s) in our database, spanning from 3/8/2011 to 8/4/2020.
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. Karnataka Soaps & Detergents Ltd's FEI number is 1000335673.
What types of violations has Karnataka Soaps & Detergents Ltd received?
Karnataka Soaps & Detergents Ltd has been cited for 4 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 Karnataka Soaps & Detergents Ltd come from?
All FDA import refusal data for Karnataka Soaps & Detergents 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.