The Himalaya Drug Company
⚠️ Moderate Risk
FEI: 3011781264 • Aurangabad • INDIA
FEI Number
3011781264
Location
Aurangabad
Country
INDIAAddress
At 24 Plot C15 Midc 5 Star, , Aurangabad, , 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
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/13/2019 | 66VCL99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northern Border Imports (DNBI) | |
| 7/18/2017 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Northeast Imports (DNEI) | |
| 7/18/2017 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Northeast Imports (DNEI) | |
| 7/18/2017 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is The Himalaya Drug Company's FDA import refusal history?
The Himalaya Drug Company (FEI: 3011781264) has 4 FDA import refusal record(s) in our database, spanning from 7/18/2017 to 11/13/2019.
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. The Himalaya Drug Company's FEI number is 3011781264.
What types of violations has The Himalaya Drug Company received?
The Himalaya Drug Company has been cited for 4 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 The Himalaya Drug Company come from?
All FDA import refusal data for The Himalaya Drug 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.