Dabur India Limited
⚠️ High Risk
FEI: 3013016335 • Dhar, Madhya Pradesh • INDIA
FEI Number
3013016335
Location
Dhar, Madhya Pradesh
Country
INDIAAddress
86 A, Kheda Industrial Area, Pithampur, , Dhar, Madhya Pradesh, 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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/14/2025 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 471CSTIC LBLG | Division of Northern Border Imports (DNBI) |
| 7/25/2025 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 197COSM COLOR | Division of Northern Border Imports (DNBI) |
| 12/22/2022 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 197COSM COLOR | Division of Northeast Imports (DNEI) |
| 3/16/2016 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 3/28/2014 | 63RBR06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | New England District Office (NWE-DO) |
Frequently Asked Questions
What is Dabur India Limited's FDA import refusal history?
Dabur India Limited (FEI: 3013016335) has 5 FDA import refusal record(s) in our database, spanning from 3/28/2014 to 8/14/2025.
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. Dabur India Limited's FEI number is 3013016335.
What types of violations has Dabur India Limited received?
Dabur India Limited 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 Dabur India Limited come from?
All FDA import refusal data for Dabur India Limited 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.