Kunal Enterprises
⚠️ Moderate Risk
FEI: 3010973316 • Delhi, Delhi • INDIA
FEI Number
3010973316
Location
Delhi, Delhi
Country
INDIAAddress
A Plot No 13, , Delhi, Delhi, 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
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).
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).
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/20/2018 | 50NGH18HENNA | Division of Southwest Imports (DSWI) | |
| 6/18/2015 | 64XPR99KERATOLYTIC N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/18/2015 | 64XPR99KERATOLYTIC N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/18/2015 | 64XPR99KERATOLYTIC N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Kunal Enterprises's FDA import refusal history?
Kunal Enterprises (FEI: 3010973316) has 4 FDA import refusal record(s) in our database, spanning from 6/18/2015 to 4/20/2018.
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. Kunal Enterprises's FEI number is 3010973316.
What types of violations has Kunal Enterprises received?
Kunal Enterprises 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 Kunal Enterprises come from?
All FDA import refusal data for Kunal Enterprises 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.