The Himalaya Drug Company
⚠️ High Risk
FEI: 3011571715 • Mehaboob Nagar, Andhra Pradesh • INDIA
FEI Number
3011571715
Location
Mehaboob Nagar, Andhra Pradesh
Country
INDIAAddress
No. 546, AA 1 & AA 2 Nandigam, Kuthar Mandal, Mehaboob Nagar, Andhra Pradesh, 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).
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).
COLOR LBLG
The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/25/2024 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 5/26/2021 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 198COLOR LBLG | Division of Northeast Imports (DNEI) |
| 12/11/2019 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 11/13/2019 | 66VCL99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northern Border Imports (DNBI) | |
| 12/14/2018 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 197COSM COLOR | Division of Northern Border Imports (DNBI) |
| 12/10/2018 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 12/6/2018 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 5/31/2016 | 63RBY99DENTAL CARIES PROPHYLACTIC N.E.C. | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 8/3/2015 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 8/3/2015 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is The Himalaya Drug Company's FDA import refusal history?
The Himalaya Drug Company (FEI: 3011571715) has 10 FDA import refusal record(s) in our database, spanning from 8/3/2015 to 11/25/2024.
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 3011571715.
What types of violations has The Himalaya Drug Company received?
The Himalaya Drug Company has been cited for 5 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.