Dabur India
⚠️ Moderate Risk
FEI: 3004326849 • District Solan, Himachal Pradesh • INDIA
FEI Number
3004326849
Location
District Solan, Himachal Pradesh
Country
INDIAAddress
220-221, Industrial Area, Baddi, District Solan, Himachal Pradesh, 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).
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).
HEALTH C
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
DR QUALITC
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the drug appears to be represented as not being recognized in an official compendium and appears its strength differs from or its quality or purity falls below, that which it purports or is represented to possess.
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.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/3/2021 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of West Coast Imports (DWCI) | |
| 8/14/2012 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | Chicago District Office (CHI-DO) | |
| 12/20/2007 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 1/25/2007 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 8/12/2005 | 66VBR99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 5/19/2005 | 66VBR99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 9/18/2004 | 54FCT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 488HEALTH C | Los Angeles District Office (LOS-DO) |
| 9/18/2004 | 54FCT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 488HEALTH C | Los Angeles District Office (LOS-DO) |
| 7/29/2004 | 63HBL99CATHARTIC N.E.C. | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Dabur India's FDA import refusal history?
Dabur India (FEI: 3004326849) has 9 FDA import refusal record(s) in our database, spanning from 7/29/2004 to 11/3/2021.
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's FEI number is 3004326849.
What types of violations has Dabur India received?
Dabur India 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 come from?
All FDA import refusal data for Dabur India 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.