Dabur India Limited
⚠️ Moderate Risk
FEI: 3008468440 • Baddi District, Himachal Pradesh • INDIA
FEI Number
3008468440
Location
Baddi District, Himachal Pradesh
Country
INDIAAddress
Nalagarg Road, , Baddi District, 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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/31/2013 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | Los Angeles District Office (LOS-DO) | |
| 1/31/2013 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | Los Angeles District Office (LOS-DO) | |
| 9/6/2011 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 10/6/2010 | 63RBY99DENTAL CARIES PROPHYLACTIC N.E.C. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Dabur India Limited's FDA import refusal history?
Dabur India Limited (FEI: 3008468440) has 4 FDA import refusal record(s) in our database, spanning from 10/6/2010 to 1/31/2013.
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 3008468440.
What types of violations has Dabur India Limited received?
Dabur India Limited has been cited for 3 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.