Dabur India Limited
⚠️ High Risk
FEI: 3004326814 • Alwar, Rajasthan • INDIA
FEI Number
3004326814
Location
Alwar, Rajasthan
Country
INDIAAddress
SP -C 162, Matsya Industrial Area, Alwar, Rajasthan, 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).
SUPPL GMP
The article appears to be a dietary supplement and it has been prepared, packed, or held under conditions that do not meet current good manufacturing practice regulations.
PESTICIDE2
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be adulterated because it contains a pesticide chemical, which is in violation of section 402(a)(2)(B). Contains:
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).
PESTICIDES
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be adulterated because it contains a pesticide chemical, which is in violation of section 402(a)(2)(B). Contains:
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.
PESTICIDE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a pesticide chemical residue, which causes the article to be adulterated within the meaning of section 402(a)(2)(B) of the FD&C Act. Bears or contains:
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/6/2025 | 66VDR99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/23/2024 | 54FCR99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 241PESTICIDE | Division of Northern Border Imports (DNBI) |
| 12/27/2023 | 66VBR99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 6/3/2015 | 54FCZ99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 3560SUPPL GMP | Division of Southwest Imports (DSWI) |
| 6/3/2015 | 54GCZ99ANIMAL BY-PRODUCTS AND EXTRACTS, N.E.C. | 3560SUPPL GMP | Division of Southwest Imports (DSWI) |
| 6/3/2015 | 54FCZ99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 3560SUPPL GMP | Division of Southwest Imports (DSWI) |
| 11/6/2013 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 11/6/2013 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 11/6/2013 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 10/17/2012 | 54FCZ99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 3721PESTICIDE2 | Los Angeles District Office (LOS-DO) |
| 9/14/2012 | 54FYY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 3721PESTICIDE2 | New York District Office (NYK-DO) |
| 8/14/2012 | 54FCZ99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 3721PESTICIDE2 | New York District Office (NYK-DO) |
| 7/14/2011 | 54FCR99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 2920PESTICIDES | San Francisco District Office (SAN-DO) |
| 8/14/2007 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Dabur India Limited's FDA import refusal history?
Dabur India Limited (FEI: 3004326814) has 14 FDA import refusal record(s) in our database, spanning from 8/14/2007 to 4/6/2025.
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 3004326814.
What types of violations has Dabur India Limited received?
Dabur India Limited has been cited for 7 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.