KARNATAKA SOAP & DETERGENTS LTD.
⚠️ High Risk
FEI: 3014424382 • Bengaluru • INDIA
FEI Number
3014424382
Location
Bengaluru
Country
INDIAAddress
#27 Industrial Subrub Bengaluru Pun, , Bengaluru, , India
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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
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).
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/13/2023 | 53AY99OTHER BABY PRODUCTS, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/7/2022 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 197COSM COLOR | Division of Northeast Imports (DNEI) |
| 12/7/2022 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 197COSM COLOR | Division of Northeast Imports (DNEI) |
| 12/7/2022 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 197COSM COLOR | Division of Northeast Imports (DNEI) |
| 12/7/2022 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 197COSM COLOR | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is KARNATAKA SOAP & DETERGENTS LTD.'s FDA import refusal history?
KARNATAKA SOAP & DETERGENTS LTD. (FEI: 3014424382) has 5 FDA import refusal record(s) in our database, spanning from 12/7/2022 to 10/13/2023.
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. KARNATAKA SOAP & DETERGENTS LTD.'s FEI number is 3014424382.
What types of violations has KARNATAKA SOAP & DETERGENTS LTD. received?
KARNATAKA SOAP & DETERGENTS 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 KARNATAKA SOAP & DETERGENTS LTD. come from?
All FDA import refusal data for KARNATAKA SOAP & 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.