Himalaya Wellness Company
⚠️ High Risk
FEI: 3025531364 • Nelamangala Taluk, Bengaluru Rural • INDIA
FEI Number
3025531364
Location
Nelamangala Taluk, Bengaluru Rural
Country
INDIAAddress
Sy. No. 107/1A & 107/2, Mallapura Village, Kasaba Hobli,Tavarekere Road, Off NH-4, Nelamangala Taluk, Bengaluru Rural, 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).
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).
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 |
|---|---|---|---|
| 12/18/2025 | 54FEL99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 1/15/2025 | 66VBA99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of West Coast Imports (DWCI) | |
| 1/3/2025 | 54FCY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 9/24/2024 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 9/24/2024 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 9/24/2024 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 9/24/2024 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 9/24/2024 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 9/24/2024 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 9/3/2024 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 9/3/2024 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 9/3/2024 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 1/16/2024 | 54FFY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 1/16/2024 | 54FFY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Himalaya Wellness Company's FDA import refusal history?
Himalaya Wellness Company (FEI: 3025531364) has 14 FDA import refusal record(s) in our database, spanning from 1/16/2024 to 12/18/2025.
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. Himalaya Wellness Company's FEI number is 3025531364.
What types of violations has Himalaya Wellness Company received?
Himalaya Wellness Company 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 Himalaya Wellness Company come from?
All FDA import refusal data for Himalaya Wellness Company 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.