Dabur India Ltd
⚠️ High Risk
FEI: 3007140482 • Baddi, Himachal Pradesh • INDIA
FEI Number
3007140482
Location
Baddi, Himachal Pradesh
Country
INDIAAddress
109 Hpsidc Industrial Area, , Baddi, Himachal 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
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).
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).
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.
COL ADDED
The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/27/2025 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/11/2025 | 66VBT99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 10/25/2024 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/21/2024 | 66VAH99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 4/12/2017 | 66YCH99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 10/8/2015 | 66YBH99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 11/21/2014 | 63RAJ99DENTAL CARIES PROPHYLACTIC N.E.C. | 75UNAPPROVED | Baltimore District Office (BLT-DO) |
| 11/21/2014 | 63RAJ99DENTAL CARIES PROPHYLACTIC N.E.C. | 75UNAPPROVED | Baltimore District Office (BLT-DO) |
| 11/21/2014 | 63RAJ99DENTAL CARIES PROPHYLACTIC N.E.C. | 75UNAPPROVED | Baltimore District Office (BLT-DO) |
| 9/22/2014 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 9/22/2014 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 3/4/2009 | 60SAR99ANTACID, N.E.C. | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 2/24/2009 | 55YY99PHARMACEUTIC NECESSITIES AND CONTAINERS, N.E.C. | Southwest Import District Office (SWI-DO) | |
| 6/21/2006 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Dabur India Ltd's FDA import refusal history?
Dabur India Ltd (FEI: 3007140482) has 14 FDA import refusal record(s) in our database, spanning from 6/21/2006 to 8/27/2025.
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 Ltd's FEI number is 3007140482.
What types of violations has Dabur India Ltd received?
Dabur India 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 Dabur India Ltd come from?
All FDA import refusal data for Dabur India 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.