HENKEL INDIA LIMITED
⚠️ Moderate Risk
FEI: 2000007155 • Kolkata • 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).
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/14/2023 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 8/10/2021 | 53IG99OTHER ORAL HYGIENE PRODUCTS, WITHOUT FLUORIDE, N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 6/11/2010 | 63RAY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 2/8/2010 | 63RAJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 118NOT LISTED | New York District Office (NYK-DO) |
| 3/13/2009 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 11UNSAFE COL | New York District Office (NYK-DO) |
| 2/24/2009 | 63RAY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 11/5/2008 | 53IC01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is HENKEL INDIA LIMITED's FDA import refusal history?
HENKEL INDIA LIMITED (FEI: 2000007155) has 7 FDA import refusal record(s) in our database, spanning from 11/5/2008 to 6/14/2023.
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 LIMITED's FEI number is 2000007155.
What types of violations has HENKEL INDIA LIMITED received?
HENKEL 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 HENKEL INDIA LIMITED come from?
All FDA import refusal data for HENKEL 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.