Henkel India Ltd.
⚠️ Moderate Risk
FEI: 3005382694 • Chennai - 18 • INDIA
FEI Number
3005382694
Location
Chennai - 18
Country
INDIAAddress
No. 3 Cenotaph Road, , Chennai - 18, , 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
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).
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/17/2008 | 63RAY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | San Francisco District Office (SAN-DO) | |
| 1/19/2008 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | Los Angeles District Office (LOS-DO) | |
| 9/29/2007 | 63RBY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 11/9/2005 | 63RAY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Henkel India Ltd.'s FDA import refusal history?
Henkel India Ltd. (FEI: 3005382694) has 4 FDA import refusal record(s) in our database, spanning from 11/9/2005 to 6/17/2008.
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. Henkel India Ltd.'s FEI number is 3005382694.
What types of violations has Henkel India Ltd. received?
Henkel India Ltd. 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 Henkel India Ltd. come from?
All FDA import refusal data for Henkel 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.